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Prosthetic rehabilitation for older dysvascular people
following a unilateral transfemoral amputation (Review)
Cumming J, Barr S, Howe TE
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2015, Issue 1
http://www.thecochranelibrary.com
Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
7DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iProsthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]
Prosthetic rehabilitation for older dysvascular people
following a unilateral transfemoral amputation
Jane Cumming1, Steve Barr2, Tracey E Howe3
1Teesside Centre for Rehabilitation Sciences, University of Teesside, Middlesbrough, UK. 2School of Health and Social Care, University
of Teesside, Tees Valley, UK. 3Glasgow City of Science, Glasgow, UK
Contact address: Jane Cumming, Teesside Centre for Rehabilitation Sciences, University of Teesside, The James Cook University
Hospital, Marton Road, Middlesbrough, TS4 3BW, UK. jane.cumming@stees.nhs.uk.
Editorial group: Cochrane Peripheral Vascular Diseases Group.
Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 1, 2015.
Review content assessed as up-to-date: 28 July 2014.
Citation: Cumming J, Barr S, Howe TE. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral
amputation. Cochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD005260. DOI: 10.1002/14651858.CD005260.pub3.
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
Dysvascularity accounts for 75% of all lower limb amputations in the UK. Around 37% of these are at transfemoral level (mid-thigh),
with the majority of people being over the age of 60 and having existing co-morbidities. A significant number of these amputees will be
prescribed a lower limb prosthesis for walking. However, many amputees do not achieve a high level of function following prosthetic
rehabilitation. This is the second update of the review first published in 2005.
Objectives
We aimed to identify and summarise the evidence from randomised controlled trials evaluating rehabilitation interventions for prosthetic
ambulation following unilateral transfemoral amputation in older dysvascular people, whether community dwelling or institutionalised.
Search methods
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register
(last searched July 2014) and Cochrane Register of Studies (CRS) (last searched 2014 Issue 6). No language restrictions were applied.
Selection criteria
Randomised and quasi-randomised controlled trials testing prosthetic rehabilitation interventions following a unilateral transfemoral
or transgenicular amputation in older (aged 60 years or above) dysvascular people.
Data collection and analysis
Two authors independently scanned the search results for potentially eligible studies and on obtaining full reports of these, selected
studies for inclusion and exclusion. Two authors independently assessed methodological quality and extracted data. No data pooling
was possible.
Main results
No new studies were identified for inclusion in this update. Of the full reports obtained for consideration, one trial was included and
four excluded. The included trial was a short-term crossover randomised trial which tested the effects of adding three seemingly identical
prosthetic weights (150 g versus 770 g versus 1625 g) to the prostheses of 10 participants with unilateral dysvascular transfemoral
amputation. Eight participants were over 60 years of age. The trial found that four participants preferred the lightest weight (150 g),
five preferred the middle weight (770 g) and one preferred the addition of the heaviest weight (1625 g).
1Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Authors’ conclusions
There is a lack of evidence from randomised controlled trials to inform the choice of prosthetic rehabilitation, including the optimum
weight of prosthesis, after unilateral transfemoral amputation in older dysvascular people. A programme of research, including ran-
domised controlled trials to examine key interventions, is urgently required in this area.
P L A I N L A N G U A G E S U M M A R Y
Artificial limb rehabilitation for older people with a leg amputated at or above the knee because of blood circulation problems
Problems with inadequate circulation in the legs (dysvascularity), particularly in people over the age of 60 years, can be so severe that
they need a leg amputated. This may be as high as at or above the knee. Accompanying medical conditions (co-morbidities) such as
diabetes, cardiovascular or heart disease can affect a person’s rehabilitation. When an above or through knee artificial limb (prosthesis) is
fitted, it is hard to regain mobility and function and some people choose to use a wheelchair. Motivation, comfort, cosmetic appearance,
functionality, reliability, ease of use, previous mobility and the extra exertion needed to use an artificial leg are all potentially important
factors that affect a person’s independence and their use of the prosthesis. Fear of falling, number of falls, social circumstances, help
and support from other people are also important influences. The review authors searched for trials comparing different types of
rehabilitation that may benefit the mobility or function in older people using an artificial limb.
Only one controlled trial was found. This had a crossover design and each of the 10 participants had three seemingly identical prosthetic
weights added to the prosthesis below the knee in a random order. The participants, nine men and one woman, were over 50 years of
age and eight were over 60 years. Over the few hours of the trial, four participants preferred the lightest weight (150 g), five preferred
the medium weight (770 g) and one preferred the heaviest weight (1625 g). Seven of the 10 people successfully ranked the weights
from lightest to heaviest. The weights did not alter the participant’s walking speed in a two-minute walk test.
The small number of participants, short exposure to the different weights in a laboratory setting and the fact that there were differences
in weight between people and also their prosthesis limits the usefulness of these findings. The artificial limbs were all modular style
prostheses.
B A C K G R O U N D
Each year, in excess of 6000 leg amputations are performed in
the United Kingdom (UK) (ISD 2004); there were over 148,000
reported hospital discharges in 1996 for limb loss in the USA
(LLRSP 2000). The number of amputees worldwide is not cur-
rently tracked by any organization. The incidence of dysvascularity
(poor circulation) increases with age and the presence of co-mor-
bidities (other medical conditions) such as diabetes. In the UK,
dysvascularity accounts for 75% of all lower limb amputations, of
which 37% are transfemoral (through the thigh). Similarly, dys-
vascularity accounts for 87% of all amputations in the USA.
Following amputation of the lower limb, a prosthesis (artificial
leg) is frequently prescribed. It is reported that older dysvascular
unilateral transfemoral amputees do not achieve a high level of
prosthetic mobility or function, particularly in comparison with
transtibial (through the calf) amputees. However, success rates
for prosthetic rehabilitation in this population differ markedly. A
recent study found that only 25% of transfemoral amputees over
the age of 50 years achieved community mobility and this figure
reduced with advancing age (Davies 2003). In contrast an earlier
study found that only 4% of this population were community
ambulators (Houghton 1992).
Some studies have attempted to identify factors that contribute
to functional outcomes for amputees. These factors include psy-
chological and social aspects, presence of co-morbidities and age.
There has also been an attempt to use such factors to predict
successful rehabilitation (Munin 2001). Clinical guidelines in the
UK (Broomhead 2003) recommend that patients should be made
aware that concurrent pathologies and previous mobility affect re-
alistic goal setting and the outcomes of prosthetic rehabilitation.
Success of prosthetic provision is frequently judged in terms of
clinical measures of impairment or function, for example walking
45 m with the prosthesis (Munin 2001). However, the relationship
between the amputee and their prosthesis is potentially more com-
2Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
plex, involving motivation, comfort, cosmetic appearance, func-
tionality, reliability, ease of use and degree of energy expenditure
during use. Transfemoral amputees have a greater level of disability
and use 65% more energy than bipedal (normal) walking (Waters
1976). The prevalence of co-existing cardiovascular disease in pa-
tients with dysvascular amputation may be as high as 75% and co-
morbid heart disease may prevent patients from achieving maxi-
mum functional independence (Roth 1998). Therefore, older dys-
vascular transfemoral amputees with cardiac abnormalities may be
at increased risk of an adverse event, such as heart failure, by being
exercised during prosthetic rehabilitation.
Patients referred to the 42 prosthetics (artificial limb) centres in
Britain and Northern Ireland are assessed for physical and psy-
chological capabilities by a multi-disciplinary team of healthcare
professionals. Patients’ and carers’ wishes are taken into account.
The outcome of the visit is a decision to prescribe a functional or
cosmetic prosthesis or to recommend an alternative form of func-
tional independence, for example a powered wheelchair. Under the
UK’s National Health Service all older amputees are issued with
a wheelchair for mobility as standard service. However, current
UK clinical guidelines (Broomhead 2003) indicate that evidence
underpinning the clinical decision path is sparse.
Older people with a unilateral transfemoral amputation are an in-
creasingly important subgroup of amputees that has been iden-
tified as having a low success rate with a prosthesis, in terms of
functional mobility and usage. Healthcare professionals involved
in amputee rehabilitation require more evidence to support clin-
ical decisions regarding a patient in this age group’s suitability
for prosthetic rehabilitation, especially when patient expectations
do not match clinical decisions. Furthermore, patients and carers
have a right to good, evidence-based information on which to base
their decisions regarding living either independently or with care
in the community. This includes whether mobility or function
will be achievable with a prosthesis, a wheelchair or a combination
of both. It is a professional’s duty to discuss the advantages and
disadvantages of each path and also to inform of any clinical risk.
It is important to review interventions to improve rehabilitation
prospects. Therefore, there was a need for a systematic review of
the evidence relating to prosthetic rehabilitation in older dysvas-
cular unilateral transfemoral amputees to inform clinical practice
O B J E C T I V E S
To identify and summarise the evidence from randomised con-
trolled trials evaluating prosthetic rehabilitation interventions fol-
lowing unilateral transfemoral or transgenicular amputation in
older dysvascular people, whether community dwelling or insti-
tutionalised.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) and quasi-randomised tri-
als (for example, randomised by date of birth or hospital record
number) that evaluated the success of prosthetic rehabilitation fol-
lowing a unilateral transfemoral amputation in older dysvascular
people.
Types of participants
Male or female participants described as:
• older adults, elderly, veteran, geriatric, aged, seniors or all
over the age of 60 years;
• living in the community or in institutional care;
and
• dysvascular;
• having a unilateral transfemoral amputation, including
transgenicular (through the knee) and provided with a
transfemoral prosthesis for walking and functional rehabilitation.
Participant characteristics of interest included age, gender, previ-
ous level of mobility and co-morbidities.
Types of interventions
Prosthetic rehabilitation included the provision of a prescribed
prosthesis postamputation that was suitable for the individual’s
needs with the aim of achieving an optimum level of function and
mobility following therapy intervention.
Interventions that may form part of the prosthetic rehabilitation
package included, but were not limited to:
• education on how to safely put on and take off the
prosthesis, dressing practice and footwear provision;
• education on skin and residual skin care, hygiene of the
prosthesis and socks, and fit of the prosthesis;
• therapeutic interventions to increase muscle power, range of
movement, improve core stability and optimise gait and control
of the prosthesis;
• balance and mobility training whilst wearing the prosthesis,
including in different environments, negotiating hazards and
getting up from a fall;
• training in functional activities of daily living, including
domestic activities;
• general advice, e.g., where to seek help, aids, adaptations,
driving, support groups and return to work.
We included trials in which participants were randomised to re-
ceive any combination of the following: usual care, a single therapy
intervention or a multiple therapy intervention. Trials comparing
two or more interventions were also to be included. The ther-
apy interventions could take place in the home, an institutional
3Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
dwelling, the community, a gymnasium or clinic setting and could
be self-supervised (for example, using exercise sheets or video), in-
dividually supervised or given as part of a supervised group.
Types of outcome measures
The main outcome of interest was ’success’ as defined below. Out-
come measures were classified according to the dimensions of the
International Classification of Functioning, Disability and Health
(ICF) (WHO 2001): impairment, activity limitation or partici-
pation restriction.
Primary outcomes
The primary measure of success was user satisfaction based on
comfort, cosmetic appearance, frequency of prosthetic use, sat-
isfaction for purpose, levels of function and independence. Ac-
ceptable measures or scales included: Prosthetic Socket Fit Com-
fort Score, Harold-Wood Stanmore Mobility Grades, Locomotor
Capabilities Index, Rivermead Mobility Index (RMI), Prosthe-
sis Evaluation Questionnaire (PEQ), Satisfaction with Prosthesis
(SATPRO), Functional Measure for Amputees and Russek’s Scale.
Secondary outcomes
Secondary outcome measures were general quality of life measures
including, but not limited to, the Sickness Impact Profile, Not-
tingham Health Profile and the MOS Short Form SF-36.
Other variables of interest included: morbidity, mortality, com-
pliance with rehabilitation, psychological distress (anxiety or de-
pression, or both), discharge placement and wheelchair use, co-
morbidities, indicators of previous level of mobility, number of
falls experienced, problems associated with dysvascularity of the
remaining limb, sensory impairment, falls risk, fear of falling, so-
cial circumstances and level of support available or required.
We intendedtoreportthe nature andnumberof any adverse events
described in included studies.
Search methods for identification of studies
2014 update searches
For this update the Cochrane Peripheral Vascular Diseases Group
Trials Search Co-ordinator (TSC) searched the Specialised Regis-
ter (last searched July 2014) and the Cochrane Register of Stud-
ies (CRS) (http://www.metaxis.com/CRSWeb/Index.asp) (last
searched 2014 Issue 6) for publications describing randomised
controlled trials of prosthetic rehabilitation for older dysvascu-
lar people following a unilateral transfemoral amputation. See
(Appendix 1) for details of the search strategy used to search the
CRS. The Specialised Register is maintained by the TSC and is
constructed from weekly electronic searches of MEDLINE, EM-
BASE, CINAHL, AMED, and through handsearching relevant
journals. The full list of the databases, journals and conference
proceedings which have been searched, as well as the search strate-
gies used are described in the (Specialised Register) section of
the Cochrane Peripheral Vascular Diseases Group module in The
Cochrane Library (www.thecochranelibrary.com).
Previous searches
For the original review we searched the database of the Cochrane
Rehabilitation and Related Therapies Field (to December 2005),
MEDLINE (January 1966 to January 2006), EMBASE (January
1980toJanuary2006),CINAHL(January1982 toJanuary2006),
AMED (January 1985 to December 2005), PSYCINFO (January
1982 to December 2005) and ASSIA (Applied Social Science In-
dex) (January 1987 to August 2005). We also searched, up to 21st
December 2005, PEDro (The Physiotherapy Evidence Database
at (http://www.pedro.fhs.usyd.edu.au/), OT Seeker (The Occu-
pational Therapy Systematic Evaluation of Evidence Database at
(http://www.otseeker.com), RECAL (specialist prosthetic and or-
thotics database at University of Strathclyde, UK), BNI (British
Nursing Index), and Rehab Base (National Rehabilitation In-
formation Clearing House). We searched the UK National Re-
search Register at (http://www.update-software.com/national/)
(up to Issue 2, 2005) and Controlled Clinical Trials at (http://
www.controlled-trials.com) (accessed June 2005) for ongoing and
recently completed trials. We inspected reference lists of articles,
checked our reference databases and contacted experts in the field.
No language restrictions were applied.
In MEDLINE (OVID-WEB), three levels of the optimal trial
search strategy developed by Robinson (Robinson 2002) were
combined with the subject-specific search. See Appendix 2 for
details of the search strategy used for MEDLINE and EMBASE
(Datastar). Similar searches adapted for each database were run
for CINAHL, AMED, PSYCINFO, BNI and ASSIA. Searches
on the remaining databases, were based on a few key words (for
example, AMPUTEE OR AMPUTATION) or specific categories
within the individual databases. Key words included Physio*,
Phys* therap*, AND Amput*, prosthe*, Lower limb OR lower
extremity.
Data collection and analysis
Selecting trials for inclusion
From the title, abstract and descriptors, two authors (JC and SB)
independently reviewed the results of the literature searches to
identify potentially relevant trials for full review. From the full
text, trials that met the selection criteria were independently se-
lected for inclusion by the same two authors. Any disagreement
not resolved by consensus would have been put forward for third
party adjudication by TH.
4Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data collection
Two authors (JC and SB) independently extracted data using a
customised data extraction tool that was tested prior to use. Con-
tacting authors of studies was not necessary.
Assessment of methodological quality
Two authors (JC and SB) independently assessed 15 aspects of
methodological quality using a scoring scheme (see Table 1) that
included items from the Cochrane Bone, Joint and Muscle Trauma
Group’s generic quality assessment scheme (denoted by ’M’), items
from the Delphi list (denoted by ’D’) (Verhagen 1998) and items
from the Maastricht-Amsterdam consensus list for Methodologi-
cal Quality Assessment (denoted by ’MAC’) (Bellamy 1997). Any
disagreement not resolved by consensus would have been put for-
ward for third party adjudication by TH.
Data analysis
Where available and appropriate, we planned to present quanti-
tative data for the outcomes listed in the inclusion criteria. We
planned to present risk ratios and 95% confidence intervals for
dichotomous outcomes, and mean differences and 95% confi-
dence intervals for continuous outcomes. Where appropriate, we
planned to pool results of comparable groups of trials using the
fixed-effect model and 95% confidence intervals. Heterogeneity
between comparable trials was to be tested using a standard chi-
squared test and considered statistically significant at P < 0.1, after
due consideration of the value of the I² result. If pooling were not
possible we stipulated that appropriate or narrative description of
results would be presented.
Sensitivity and subgroup analyses
We planned to perform sensitivity analyses, where indicated and
appropriate, to investigate the effects of allocation concealment,
methodological quality, and intention-to-treat analysis. Where the
data allowed, we also planned separate outcome analyses to test
the following hypotheses:
• prosthetic rehabilitation is equally successful in males and
females;
• success does not depend on the duration and (or) intensity
of prosthetic rehabilitation;
• success does not depend on the setting in which the
prosthetic rehabilitation is delivered;
• success does not depend on the level or type of supervision
of prosthetic rehabilitation.
R E S U L T S
Description of studies
Results of the search
2014 update searches
See Figure 1.
5Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 1. Study flow diagram.
Previous searches
The Cochrane Peripheral Vascular Diseases (PVD) Group pro-
vided citations for 17 trials of which four were considered as po-
tentially eligible.
The MEDLINE search (January 1966 to 5th July 2005) yielded
1118 journal articles of which 12 were considered as potentially
eligible.
The EMBASE search (1980 to 10th August 2005) produced 319
journal articles of which 12 were considered as potentially eligible.
The CINAHL search (1982 to 1st August 2005) produced 73
papers of which four were considered as potentially eligible.
The PSYCINFO search (1982 to 4th August 2005) produced 705
hits of which five were considered as potentially eligible.
We found no additional papers through searching AMED, ASSIA,
PEDro, RECAL, BNI, OTseeker or Rehab base. We did not locate
any ongoing or unpublished trials.
Since the searches on the databases were run separately there was
some duplication in the citations selected for retrieval of full re-
ports. In all, we obtained the full reports of 38 studies. From these,
five trials were selected for inclusion or exclusion in the main re-
view. The only trial (Meikle 2003) suitable for inclusion appeared
in the citations provided by the Cochrane Peripheral Vascular Dis-
eases Group and in the MEDLINE and EMBASE searches.
Included studies
The only included study (Meikle 2003) was a crossover ran-
domised trial which tested the effects of adding three seemingly
identical prosthetic weights (150 g versus 770 g versus 1625 g)
6Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
in a randomised order to the prostheses of 10 amputees. All the
participants had undergone transfemoral amputations for vascu-
lar reasons. The mean age was 65 years although two participants
were aged between 50 and 60 years. One participant was female.
All participants were community ambulators, with at least three
months since their amputation, and had similar activity levels. The
study compared the effects of adding three different weights below
the knee joint to each participant’s prosthesis during a single ses-
sion. The primary outcome measure was participant preference,
which was based on the rank order of preference of the participant
for the three different weights. This was interpreted as equating
to user satisfaction. The other main outcome measure of the trial
was participant gait speed as measured by the two minute walk
test (2MWT). This is a laboratory-based measure of mobility that
does not satisfy the inclusion criteria of this review. Also investi-
gated was the participant’s ability to identify the weight that had
been added.
See the Characteristics of included studies for summary details.
Excluded studies
Fourtrialswere excluded(Alexander1978; Godfrey1977; Presern-
Strukel 2000; Wong 2002). See the Characteristics of excluded
studies for summary details.
Risk of bias in included studies
See Table 2 for details of the quality assessment of the single in-
cluded study (Meikle 2003). The interventions applied to each
participant were in randomised order but the procedure of ran-
domisation was not described. During the study, effective mea-
sures were taken to blind both the assessor and the study partici-
pants to each intervention, that is the weight added to the pros-
thesis. There were no participant withdrawals as this was a sin-
gle-session laboratory-based study with no follow up. The inclu-
sion and exclusion criteria and participant characteristics were all
clearly described.
Effects of interventions
Only one study was included (Meikle 2003). Of the 10 partici-
pants in the trial four preferred the placebo weight (150 g), five
preferred the 770 g weight and one preferred the 1625 g weight.
Seven participants successfully ranked the weights from lightest to
heaviest. Meikle 2003 reported there was no significant difference
in participant gait speed with the addition of the three different
weights to the prosthesis.
The authors in this study used the term weight rather than the
more correct mass to describe the additions to the prosthesis. The
authors’ terminology has been retained in this review as it is more
commonly used outside the scientific community.
D I S C U S S I O N
Older people with a unilateral transfemoral amputation are an
increasingly important subgroup of amputees that is identified as
having a low success rate with a prosthesis, in terms of functional
mobility and usage. It is disappointing, therefore, that there is a
paucity of good quality and reliable research evidence that can be
used to inform clinical practice.
Only one randomised trial satisfied the eligibility criteria for this
review. This trial (Meikle 2003) was judged to be of moderate
methodological quality and hence the results should be interpreted
with caution. A deficiency of evidence may also apply to other
transfemoral amputee groups as only one randomised controlled
trial was identified investigating the effects of a therapeutic inter-
vention within prosthetic rehabilitation in young traumatic trans-
femoral amputees (Yigiter 2002).
Although the weight of an amputee’s prosthetic limb is clinically
important, particularly from the point of view of amputee sat-
isfaction, the included study provided only minimal evidence of
effect. Indeed, the small number of participants, limitations of the
crossover design, the short duration of the intervention, the lab-
oratory nature of the trial, the absence of follow up and limited
nature of outcome assessment prevent such a trial from providing
adequate evidence to inform the prescription of prosthetic limbs.
As acknowledged by the trial authors, the most the trial results do
is to challenge an assumption, if made, that patients will always
prefer the lightest prosthesis. Even this assertion needs to be seen
in the context of the very short-term nature of the intervention (a
few hours). Other issues also merit consideration. The interven-
tions in this study were all identical (weight added to a prosthesis)
and were absolute values that were identical between participants.
However, the body weight of the individual participants varied
from 52 kg to 112 kg and thus the relative mass (weight) was dif-
ferent between participants. The pre-intervention weight of the
prosthesis used by each participant also differed, from 2.8 to 4.2
kg. Therefore, in both cases the perceived weight that was added
to the prosthesis may have been different. Participants were only
permitted 5 to 10 minutes to familiarise themselves with the new
prosthetic weight before taking the walk test. It may have been that
in this population participants would have benefited from a longer
period to acclimatise to the added weight of the prosthetic limb.
Participants used their own prosthetic limbs; these were all en-
doskeletal prostheses with modified quadrilateral sockets and the
same types of suspension. However, the knee and foot prosthetic
components were not standardised between participants. These
factors, either individually or in combination, could potentially
confound the results of this study. The authors (Meikle 2003) also
acknowledge the difficulties in performing trials in rehabilitation
where the question and the interpretation of the findings may not
be quite as straightforward as they initially appear.
Certainly, research on the optimum weight of a prosthetic limb
7Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
in this population would be useful. Such research should include
assessment of the known high energy expenditure costs that older
unilateral dysvascular transfemoral amputees experience in the
presence of co-morbidities. A much larger sample size, standardis-
ation of prosthetic components, randomisation into separate treat-
ment groups, longer trial duration and appropriate follow up may
provide the necessary clinically relevant data on the optimum
weight of a prosthetic limb for this population.
A U T H O R S ’ C O N C L U S I O N S
Implications for practice
There is a lack of evidence from randomised controlled trials to
inform the choice of prosthetic rehabilitation, including the op-
timum weight of a prosthesis, after unilateral transfemoral ampu-
tation in older dysvascular people.
Implications for research
Most of the research in this area of clinical practice has been
through cohort studies based upon prognostic indicators of suc-
cess. These have included psychological and cognitive aspects, co-
morbidities, functional abilities, compliance and the use of assess-
ment tools. This is not enough to inform practice. There is an ur-
gent need for reliable evidence from high quality and sufficiently
powered randomised controlled trials on the success (for exam-
ple, user satisfaction based on comfort, cosmetic appearance, fre-
quency of prosthetic use, satisfaction for purpose, levels of func-
tion and independence) of key prosthetic rehabilitation interven-
tions following transfemoral amputation in older dysvascular peo-
ple. Research topic priorities informed by clinicians and amputees
need to be ascertained beforehand in order to set up a research
programme to address the important questions in this clinical area.
A C K N O W L E D G E M E N T S
We would like to thank Julie Hogg, University of Teesside, Mid-
dlesbrough for her assistance with developing the search strategies
for a number of the databases in the original review; and Heather
Smart, The National Centre for Education and Training in Pros-
thetics and Orthotics for developing the RECAL search strategy
for the original review. We are also grateful to the Cochrane Col-
laborative Review Group on Peripheral Vascular Diseases for their
help and patience and to the Cochrane Consumer Network for
updating the Plain Language Summary in the previous review. We
thank Helen Handoll and Keith Rome, Teesside Centre for Reha-
bilitation Science, Middlesbrough, for their encouragement and
helpful discussions on rehabilitation research.
R E F E R E N C E S
References to studies included in this review
Meikle 2003 {published data only}
Meikle B, Boulias C, Pauley T, Devlin M. Does increased
prosthetic weight affect gait speed and patient preference
in dysvascular transfemoral amputees?. Archives of Physical
Medicine and Rehabilitation 2003;84(11):1657–61. [:
CN–00453251]
References to studies excluded from this review
Alexander 1978 {published data only}
Alexander J, Goodrich R. Videotape immediate playback: a
tool in rehabilitation of persons with amputations. Archives
of Physical Medicine and Rehabilitation 1978;59(3):141–4.
Godfrey 1977 {published data only}
Godfrey CM, Brett R, Jousse AT. Foot mass and effect on
gait in the prosthetic limb. Archives of Physical Medicine and
Rehabilitation 1977;586(6):268–9.
Presern-Strukel 2000 {published data only}
Presern-Strukelj M, Poredos P. The influence of
electrostimulation on the circulation of the remaining leg in
patients with one-sided amputation. Angiology 2002;53(3):
329–35.
Wong 2002 {published data only}
Wong CK, Edelstein JE. Unna and elastic post operative
dressings: Comparison of their effects on function of adults
with amputation and vascular disease. Archives of Physical
Medicine and Rehabilitation 2000;81(9):1191–8.
Additional references
Bellamy 1997
Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell
P, et al.Recommendations for a core set of outcome measures
for future phase III clinical trials in knee, hip, and hand
osteoarthritis: Consensus development at OMERACT III.
Journal of Rheumatology 1997;24(4):799–802.
Broomhead 2003
Broomhead P, Dawes D, Lambert A, Shepherd R, Quinlivan
D. Evidence based Clinical Guidelines for the Physiotherapy
Management of Adults with Lower Limb Prostheses.
Chartered Society of Physiotherapy. London, 2003.
Davies 2003
Davies B, Datta D. Mobility outcome following unilateral
lower limb amputation. Prosthetics and Orthotics
International 2003;27(3):186–90.
8Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Houghton 1992
Houghton AD, Taylor PR, Thurlow S, Rootes E, McColl.
Success rates for rehabilitation of vascular amputees:
implications for preoperative assessment and amputation
level. British Journal of Surgery 1992;79(8):753–5.
ISD 2004
Information and Statistics Division NHS Scotland. The
amputee statistical database for the United Kingdom 2002/
03. http://www.nasdab.co.uk/pdf.pl?file=nasdab/news/
Intro.pdf (accessed 12 October 2004).
LLRSP 2000
Limb Loss Research and Statistics Program. Estimates of
incidence (rate) of limb loss and congenital limb absence
in the United States. http://www.amputee-coalition.org/
llrsp˙update/llrsp˙update˙2000.html (accessed 18 August
2004).
Munin 2001
Munin MC, Espejo-De Guzman MC, Boninger ML,
Fitzgerald SG, Penrod LE, Singh J. Predictive factors
for successful early prosthetic ambulation among lower-
limb amputees. Journal of Rehabilitation Research and
Development 2001;38(4):379–84.
Robinson 2002
Robinson KA, Dickerson K. Development of a highly
sensitive search strategy for the retrieval of reports of
controlled trials using PubMed. International Journal of
Epidemiology 2002;31(1):150–3.
Roth 1998
Roth EJ, Park KL, Sullivan WJ. Cardiovascular disease in
patients with dysvascular amputation. Archives of Physical
Medicine and Rehabilitation 1998;79(2):205–15.
Verhagen 1998
Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M,
Bouter LM, et al.The Delphi list: a criteria list for quality
assessment of randomized clinical trials for conducting
systematic reviews developed by Delphi consensus. Journal
of Clinical Epidemiology 1998;51(12):1235–41.
Waters 1976
Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of
walking of amputees: the influence of level of amputation.
Journal of Bone and Joint Surgery 1976;58(1):42–6.
WHO 2001
World Health Organization. International classification of
functioning, disability and health (ICF). Geneva: World
Health Organisation, 2001. [: ISBN 9241545429. m]
Yigiter 2002
Yigiter K, Sener G, Erbahceci F, Bayer K, Ulger OG,
Akdogan S. A comparison of traditional prosthetic training
versus propioceptive neuromuscular facilitation resistive
gait training with trans-femoral amputees. Prosthetics and
Orthotics International 2002;26:213–7.
References to other published versions of this review
Cumming 2006
Cumming J, Barr S, Howe TE. Prosthetic rehabilitation for
older dysvascular people following a unilateral transfemoral
amputation. Cochrane Database of Systematic Reviews 2006,
Issue 4. [DOI: 10.1002/14651858.CD005260.pub2]
Howe 2005
Howe TE, Cumming JCO, Barr S. Prosthetic rehabilitation
for older dysvascular people following a unilateral
transfemoral amputation. Cochrane Database of
Systematic Reviews 2005, Issue 2. [DOI: 10.1002/
14651858.CD005260]
∗
Indicates the major publication for the study
9Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Meikle 2003
Methods Study design: Single-centre, randomised, double blind crossover trial
Exclusions post randomisation: None.
Losses to follow up: Of 12 participants that were eligible for the study, 2 refused to partic-
ipate
Participants Country: Canada.
Setting: Community.
No. of participants: 10.
Inclusion criteria: Loss of limb due to peripheral vascular disease; over the age of 50;
ambulant in the community for minimum of 3 months since amputation; independent
community ambulator with prosthesis with or without aids; ability to walk for 2 minutes
consecutively
Exclusion criteria: Cognitive impairment sufficient to limit ability to participate
Interventions Single session assessment. Added weight to prosthetic limb below the knee: 150 g (placebo)
versus 770 g versus 1625 g
Duration: One day.
Follow up: None - single assessment only.
Outcomes Primary: 2 minute walk test.
Secondary: Participant preference in terms of weight applied
Notes No follow up following trial period.
Risk of bias
Bias Authors’ judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B - Unclear
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Alexander 1978 Only two transfemoral amputees in trial. Inadequate randomisation
Godfrey 1977 Inadequate randomisation described and no participant demographics
Presern-Strukel 2000 Outcome measures used in this trial did not meet the outcomes selected for this review
10Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Wong 2002 Pre-prosthetic rehabilitation intervention which falls out of the scope of this review
11Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
D A T A A N D A N A L Y S E S
This review has no analyses.
A D D I T I O N A L T A B L E S
Table 1. Quality assessment items and possible scores
Items and scores
M-A (D1b). Was the assigned treatment adequately concealed prior to allocation?
2 = method did not allow disclosure of assignment.
1 = small but possible chance of disclosure of assignment or unclear.
0 = quasi-randomised or open list/tables.
Cochrane code: Clearly Yes = A; Not sure = B; Clearly No = C
M-B (D8). Were the outcomes of withdrawn participants described and included in the analysis (intention to treat)?
2 = withdrawals well described and accounted for in analysis.
1 = withdrawals described and analysis not possible.
0 = no mention, inadequate mention, or obvious differences and no adjustment
M-C (D4). Were the outcome assessors blinded to treatment status?
2 = effective action taken to blind assessors.
1 = small or moderate chance of unblinding of assessors.
0 = not mentioned or not possible.
M-D (D2). Were the treatment and control groups comparable at entry?
2 = good comparability of groups, or confounding adjusted for in analysis.
1 = confounding small; mentioned but no adjustment made.
0 = large potential for confounding, or not discussed.
M-E (D6). Were the participants blind to assignment status after allocation?
2 = effective action taken to blind participants.
1 = small or moderate chance of unblinding of participants.
0 = not possible, or not mentioned (unless double-blind), or possible but not done
M-F (D5). Were the treatment providers blind to assignment status?
2 = effective action taken to blind treatment providers.
1 = small or moderate chance of unblinding of treatment providers.
0 = not possible, or not mentioned (unless double-blind), or possible but not done
M-G. Were care programmes, other than the trial options, identical?
2 = care programmes clearly identical.
1 = clear but trivial differences.
0 = not mentioned or clear and important differences in care programmes
M-H (D3). Were the inclusion and exclusion criteria clearly defined?
2 = clearly defined.
1 = inadequately defined.
12Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. Quality assessment items and possible scores (Continued)
0 = not defined.
M-I. Were the interventions clearly defined?
2 = clearly defined interventions are applied with a standardised protocol.
1 = clearly defined interventions are applied but the application protocol is not standardised.
0 = intervention and/or application protocol are poorly or not defined
M-J. Were the outcome measures used clearly defined?
2 = clearly defined.
1 = inadequately defined.
0 = not defined.
M-K. Were tests used in outcome assessment clinically useful?
2 = optimal.
1 = adequate.
0 = not defined, not adequate.
M-L. Was the surveillance active, and of clinically appropriate duration (i.e. at least 3 months)?
2 = active surveillance and appropriate duration (3 months follow up or more).
1 = active surveillance, but inadequate duration (less than 3 months follow up).
0 = surveillance not active or not defined.
D7. Were point estimates and measures of variability presented for the primary outcome measures?
2 = yes.
1 = point estimates, but no measures of variability presented.
0 = vague descriptions.
MAC-1. Was the compliance rate in each group likely to cause bias?
2 = compliance well described and accounted for in analysis.
1 = compliance well described but differences between groups not accounted for in analysis.
0 = compliance unclear.
MAC-2. Was there a description of adverse effects of the intervention(s)?
2 = well described.
1 = poorly described.
0 = not described.
Table 2. Quality assessment of included study
Items Scores
Was the assigned treatment adequately concealed prior to alloca-
tion?
0
Were the outcomes of withdrawn participants described and in-
cluded in the analysis (intention to treat)?
0
Were the outcome assessors blinded to treatment status? 2
13Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 2. Quality assessment of included study (Continued)
Were the treatment and control groups comparable at entry 2
Were the participants blind to assignment status after allocation? 1
Were the treatment providers blind to assignment status? 2
Were care programmes, other than trial options, identical? 2
Were the inclusion and exclusion criteria clearly defined? 2
Were the interventions clearly defined? 2
Were the outcome measures used clearly defined? 2
Were tests used in outcome assessment clinically useful? 1
Was the surveillance active, and of clinically appropriate duration
(i.e. at least 3 months)?
0
Were point estimates and measures of variability presented for the
primary outcome measures?
0
Was the compliance rate in each group likely to cause bias? 0
Was there a description of adverse effects of the intervention(s)? 0
A P P E N D I C E S
Appendix 1. CRS search strategy
#1 MESH DESCRIPTOR Arteriosclerosis 863
#2 MESH DESCRIPTOR Arteriolosclerosis EXPLODE ALL
TREES
0
#3 MESH DESCRIPTOR Arteriosclerosis Obliterans 69
#4 MESH DESCRIPTOR Atherosclerosis 475
#5 MESH DESCRIPTOR Arterial Occlusive Diseases 694
14Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
#6 MESH DESCRIPTOR Intermittent Claudication 661
#7 MESH DESCRIPTOR Ischemia 712
#8 MESH DESCRIPTOR Peripheral Vascular Diseases EX-
PLODE ALL TREES
2060
#9 (atherosclero* or arteriosclero* or PVD or PAOD or PAD ):
TI,AB,KY
6830
#10 ((arter* or vascular or vein* or veno* or peripher*) near3 (oc-
clus* or reocclus* or re-occlus* or steno* or restenos* or ob-
struct* or lesio* or block* or harden* or stiffen* or obliter*) ):
TI,AB,KY
5524
#11 (peripheral near3 dis*):TI,AB,KY 2486
#12 (claudic* or IC):TI,AB,KY 2230
#13 (isch* or CLI):TI,AB,KY 16857
#14 arteriopathic:TI,AB,KY 7
#15 dysvascular*:TI,AB,KY 8
#16 (leg near3 (occlus* or reocclus* or re-occlus* or steno* or
restenos* or obstruct* or lesio* or block* or harden* or stiffen*
or obliter*) ):TI,AB,KY
68
#17 (limb near3 (occlus* or reocclus* or re-occlus* or steno* or
restenos* or obstruct* or lesio* or block* or harden* or stiffen*
or obliter*) ):TI,AB,KY
92
#18 ((lower near3 extrem*) near3 (occlus* or reocclus* or re-oc-
clus* or steno* or restenos* or obstruct* or lesio* or block* or
harden* or stiffen* or obliter*) ):TI,AB,KY
63
#19 ((iliac or femoral or popliteal or femoro* or fempop* or crural)
near3(occlus* or reocclus* or re-occlus* or steno* or restenos*
or obstruct* or lesio* or block* or harden* or stiffen* or
obliter*) ):TI,AB,KY
641
#20 MESH DESCRIPTOR Leg EXPLODE ALL TREES WITH
QUALIFIERS BS
1061
#21 MESH DESCRIPTOR Iliac Artery 135
#22 MESH DESCRIPTOR Popliteal Artery 246
15Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
#23 MESH DESCRIPTOR Femoral Artery 718
#24 MESH DESCRIPTOR Tibial Arteries 30
#25 (((femor* or iliac or popliteal or fempop* or crural or poplite*
or infrapopliteal or inguinal or femdist* or inguinal or infrain-
quinal or tibial) near3 (occlus* or reocclus* or re-occlus* or
steno* or restenos* or obstruct* or lesio* or block* or harden*
or stiffen* or obliter*) )):TI,AB,KY
752
#26 MESH DESCRIPTOR Gangrene EXPLODE ALL TREES 62
#27 MESH DESCRIPTOR Diabetic Angiopathies EXPLODE
ALL TREES
1852
#28 gangren*:TI,AB,KY 235
#29 (diabet* near3 angio*):TI,AB,KY 958
#30 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR
#9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR
#16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR
#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29
34061
#31 MESHDESCRIPTORAmputationEXPLODEALLTREES 266
#32 MESH DESCRIPTOR Amputees EXPLODE ALL TREES 66
#33 (leg near3 amput*):TI,AB,KY 42
#34 (extrem* near3 amput*):TI,AB,KY 57
#35 (limb near3 amput*):TI,AB,KY 124
#36 exarticulat*:TI,AB,KY 0
#37 disarticulat*:TI,AB,KY 11
#38 transgeni*:TI,AB,KY 97
#39 #31 OR #32 OR #33 OR #34 OR #35 OR #36 OR #37 OR
#38
547
#40 MESH DESCRIPTOR Artificial Limbs 89
#41 MESH DESCRIPTOR Joint Prosthesis EXPLODE ALL
TREES
1448
16Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
#42 prosthe*:TI,AB,KY 7116
#43 (artificial near3 (leg or limb or low or extremity)):TI,AB,KY 19
#44 MESH DESCRIPTOR Rehabilitation EXPLODE ALL
TREES
13035
#45 rehabilit*:TI,AB,KY 19004
#46 #40 OR #41 OR #42 OR #43 OR #44 OR #45 33733
#47 #30 AND #39 AND #46 55
Appendix 2. Search strategies for MEDLINE (OVID-WEB) and EMBASE (Datastar)
MEDLINE (OVID-WEB) EMBASE (Datastar)
1 randomized controlled trial.pt.
2 controlled clinical trial.pt.
3 randomized controlled trials.sh.
4 random allocation.sh.
5 double blind method.sh.
6 single blind method.sh.
7 or/1-6
8 (animals not human).sh.
9 7 not 8
10 clinical trial.pt.
11 exp Clinical Trials/
12 (clin$ adj25 trial$).ab,ti.
13 ((singl$ or doubl$ or trebl$) adj25 (blind$ or mask$)).ab,ti.
14 placebo$.sh.
15 placebo$.ab,ti.
1 RANDOMIZED-CONTROLLED-TRIAL#.DE.
2 CLINICAL-TRIAL#.DE.
3 RANDOMISED-CONTROLLED-TRIAL.MJ.
4 RANDOMISATION.W.MJ.
5 DOUBLE-BLIND-PROCEDURE.MJ.
6 SINGLE-BLIND-PROCEDURE.MJ.
7 1 OR 2 OR 3 OR 4 OR 5 OR 6
8 ANIMAL.W..MJ.
9 8 NOT HUMAN
10 7 NOT 9
11 CLINICAL-TRIAL#.DE.
12 CLINICAL-TRIAL.MJ.
13 (SINGLE OR DOUBLE OR TREBLE) ADJ (BLIND$2 OR
MASK$3)
14 PLACEBO.W..MJ.
15 PLACEBO#.W..DE.
16 random$.ab,ti.
17 research design.sh.
18 or/10-17
19 18 not 8
20 19 not 9
21 comparative study.sh.
22 exp evaluation studies/
23 follow up studies.sh.
24 prospective studies.sh.
25 (control$ or prospectiv$ or volunteer$).ab,ti.
26 or/21-25
27 26 not 8
16 RANDOM$4.TI.
17 RANDOM$4.AB.
18 METHODOLOGY.W..MJ.
19 OR/11-18
20 18 NOT 9
21 19 NOT 10
22 COMPARATIVE-STUDY.MJ.
23 EVALUATION.W..MJ.
24 EVALUATION#.W..DE.
25 FOLLOW-UP.MJ.
26 PROSPECTIVE STUDY.MJ.
17Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
28 27 not (9 or 20)
29 9 or 20 or 28
30 exp amputation/
27 (CONTROL$3 OR PROSPECTIVE OR VOLUNTEER$3)
.AB.
28 (CONTROL$3 OR PROSPECTIVE OR VOLUNTEER$3)
.TI.
29 OR/22-28
30 29 NOT 9
31 amput$.mp.
32 exp amputees/
33 30 or 31 or 32
34 exp artificial limbs/
35 exp artificial leg/
36 prosthe$.mp.
37 34 or 35 or 36
38 exp rehabilitation/ or exp rehabilitation nursing/ or exp reha-
bilitation centers/ or exp rehabilitation, vocational/
39 exp exercise therapy/ or exp exercise/ or exp exercise test/ or
exp exercise movement techniques/ or exp exercise tolerance/
40 exp “physical education and training”/
41 exp physical therapy techniques/
42 exp physical fitness/
43 exp movement/ or exp exercise movement techniques/
44 exp gait/
45 exp locomotion/
31 30 NOT 10
32 10 OR 21 OR 31
33 AMPUTATION#.W..DE.
34 AMPUTATION.W..MJ.
35 AMPUT$
36 DISABLED-PERSON#.DE.
37 OR/33-36
38 LIMB-PROSTHESIS#.DE.
39 PROSTHE$
40 ARTIFICIAL ADJ LIMB
41 OR/38-40
42 REHABILITATION#.W..DE. OR REHABILITATION-
CENTER#.DE. OR REHABILITATION-MEDICINE#DE.
OR NURSING#.W..DE.
43 KINESIOTHERAPY#.W..DE.
44 EX-
ERCISE#.W..D DYNAMIC-EXERCISE#.DE. OR EXERCISE-
ELECTROCARDIOGRAPHY#.DE. OR ERGOMETRY#.W..
DE. OR ISOKINETIC-EXERCISE#.DE. OR STATIC-EXER-
CISE#.DE. OR EXERCISE-TEST#.DE. OR EXERCISE TOL-
ERANCE#.DE.
45 PHYSIOTHERAPY#.W..DE.
46 exp walking/
47 exp musculoskeletal equilibrium/
48 exp contracture/ or exp posture/ or exp movement/
49 exp exertion/ or exp muscle, skeletal/ or exp muscle contrac-
tion/ or exp muscles/ or exp leg/ or exp isometric contraction/
50 exp weight bearing/
51 exp weight perception/
52 exp biomechanics/
53 exp energy metabolism/ or exp energy intake/
54 exp efficiency/
55 exp kinetics/
56 or exp muscles/ or exp tarsal joints/ or exp ankle/ or exp elec-
tromyography/ or exp kinesiology, applied/ or exp foot/
57 (patient adj satisfaction).mp.
58 exp physician’s practice patterns/ or exp practice guidelines/
59 exp clinical protocols/
60 exp treatment outcome/
46 TRAINING#.W..DE.
47 PHYSICAL-CAPACITY#.DE. OR PHYSICAL-AC-
TIVITY#.DE. OR PHYSICAL-ACTIVITY-CAPACITY-AND-
PERFORMANCE#.DE. OR COMPLIANCE-PHYSICAL#.
DE. OR PHYSICAL-DISABILITY#.DE. OR PHYSICAL-ED-
UCATION#.DE. OR PHYSICAL-STRESS#.DE. OR FIT-
NESS#.W..DE. OR IMMOBILIZATION#.W..DE. OR PHYS-
ICAL-MEDICINE#.DE. OR PHYSICAL-PERFORMANCE#.
DE. OR PHYSICAL-RESISTANCE#.DE. OR PHYSIOTHER-
APIST#.W..DE.
48 MOVEMENT-PHYSIOLOGY#.DE. OR LEG-MOVE-
MENT#.DE. OR PASSIVE-MOVEMENT#.DE. OR MOVE-
MENT-PERCEPTION#.DE. OR MOTION#,W..DE. OR
MOVEMENT THERAPY#.DE.
49 GAIT#.W..DE. OR GAIT-DISORDER#.DE.
50 LOCOMOTION#.W..DE.
51 WALKING#.W..DE. OR WALKING-AID#.DE. OR
WALKING-SPEED#.DE.
52 JOINT-MOBILITY#.DE. OR PATIENT-MOBILITY#.DE.
18Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
53 BALANCE-DISORDER#.DE.
54 BODY-EQUILIBRIUM#.DE.
55 CONTRACTURE#.W..DE. OR JOINT-CONTRAC-
TURE#.DE. OR HIP-CONTRACTURE#.DE.
56 BODY-POSTURE#.DE.
57 MOVEMENT-PHYSIOLOGY#.DE. OR MOVEMENT-
PERCEPTION#DE. ORLEG-MOVEMENT#.DE. ORLIMB-
MOVEMENT#DE. OR PASSIVE-MOVEMENT#.DE. OR
MOVEMENT-THERAPY#.DE.
58 WEIGHT-BEARING#.DE.
59 BIOMECHANICS#.W..DE.
60 ENERGY#.W..DE. OR ENERGY-
BALANCE#.DE. OR ENERGY-CONSERVATION#.DE. OR
ENERGY-CONSUMPTION#.DE. OR ENERGY-COST#.DE
61 exp aptitude/
62 exp feedback/
63 or/38-62
64 29 and 33 and 37 and 63
61 KINETICS#.W..DE.
62 PATIENT-SATISFACTION#.DE.
63 TREATMENT-OUTCOME#.DE.
64 APTITUDE#.W..DE.
65 MOTOR-PERFORMANCE#.DE. OR PHYSICAL PER-
FORMANCE#.DE.
66 OR/42-65
67 32 AND 37 AND 41 AND 66
W H A T ’ S N E W
Last assessed as up-to-date: 28 July 2014.
Date Event Description
11 December 2014 New search has been performed New searches run. No new included studies. Minor
text changes made
11 December 2014 New citation required but conclusions have not
changed
New searches run. No new included studies. No
change to conclusions
19Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
H I S T O R Y
Protocol first published: Issue 2, 2005
Review first published: Issue 4, 2006
Date Event Description
4 October 2010 New search has been performed CENTRAL search was amended and re-run and no new trials found
28 October 2008 New search has been performed Searches re-run and no new trials found.
23 May 2008 Amended Converted to new review format.
30 April 2007 Amended Minor copy edit to correct incomplete last sentence in authors conclusions
and to correct Acknowledgements. Updated search dates. No changes to con-
clusions
C O N T R I B U T I O N S O F A U T H O R S
JC conceived the review and designed the protocol with TH and SB. JC and SB provided and wrote the content-specific and clinical
aspects of the protocol. TH co-ordinated the protocol development, including devising the quality assessment scheme, completed the
draft protocol and with JC secured funding. JC and SB developed the revised search strategies at the review stage, ran these and sifted
through the search results; they obtained copies of the trial reports, performed study selection, reviewed the included trial and produced
the first and successive drafts of the review. TH continued to guide the review process and provided critical feedback. JC and SB are
the guarantors of the review.
D E C L A R A T I O N S O F I N T E R E S T
SB: Received small grant from Physiotherapy Research Fund which assisted with some expenses associated with undertaking the review
JC: Received small grant from Physiotherapy Research Fund and Health Foundation which assisted with expenses associated with
undertaking the review, including review writing and expenses for travel and accommodation for presentation at the International
Society of Prosthetics and Orthotics 2007 and Physiotherapy Congress 2008
TH: None known
S O U R C E S O F S U P P O R T
20Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Internal sources
• University of Teesside, UK.
• South Tees Hospitals NHS Trust, James Cook University Hospital, Middlesbrough, UK.
• Glasgow Caledonian University, Glasgow, UK.
External sources
• Health Foundation, London, UK.
• The Physiotherapy Research Foundation of the Chartered Society of Physiotherapy (Charitable Trust), London, UK.
• Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.
The PVD Group editorial base is supported by the Chief Scientist Office.
I N D E X T E R M S
Medical Subject Headings (MeSH)
∗Artificial Limbs [psychology]; Amputation [methods; ∗rehabilitation]; Femur [∗surgery]; Leg [blood supply; surgery]; Patient Satis-
faction
MeSH check words
Aged; Humans; Middle Aged
21Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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CD005260

  • 1. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Cumming J, Barr S, Howe TE This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 1 http://www.thecochranelibrary.com Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 2. T A B L E O F C O N T E N T S 1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 7DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iProsthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 3. [Intervention Review] Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation Jane Cumming1, Steve Barr2, Tracey E Howe3 1Teesside Centre for Rehabilitation Sciences, University of Teesside, Middlesbrough, UK. 2School of Health and Social Care, University of Teesside, Tees Valley, UK. 3Glasgow City of Science, Glasgow, UK Contact address: Jane Cumming, Teesside Centre for Rehabilitation Sciences, University of Teesside, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK. jane.cumming@stees.nhs.uk. Editorial group: Cochrane Peripheral Vascular Diseases Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 1, 2015. Review content assessed as up-to-date: 28 July 2014. Citation: Cumming J, Barr S, Howe TE. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation. Cochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD005260. DOI: 10.1002/14651858.CD005260.pub3. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. A B S T R A C T Background Dysvascularity accounts for 75% of all lower limb amputations in the UK. Around 37% of these are at transfemoral level (mid-thigh), with the majority of people being over the age of 60 and having existing co-morbidities. A significant number of these amputees will be prescribed a lower limb prosthesis for walking. However, many amputees do not achieve a high level of function following prosthetic rehabilitation. This is the second update of the review first published in 2005. Objectives We aimed to identify and summarise the evidence from randomised controlled trials evaluating rehabilitation interventions for prosthetic ambulation following unilateral transfemoral amputation in older dysvascular people, whether community dwelling or institutionalised. Search methods For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched July 2014) and Cochrane Register of Studies (CRS) (last searched 2014 Issue 6). No language restrictions were applied. Selection criteria Randomised and quasi-randomised controlled trials testing prosthetic rehabilitation interventions following a unilateral transfemoral or transgenicular amputation in older (aged 60 years or above) dysvascular people. Data collection and analysis Two authors independently scanned the search results for potentially eligible studies and on obtaining full reports of these, selected studies for inclusion and exclusion. Two authors independently assessed methodological quality and extracted data. No data pooling was possible. Main results No new studies were identified for inclusion in this update. Of the full reports obtained for consideration, one trial was included and four excluded. The included trial was a short-term crossover randomised trial which tested the effects of adding three seemingly identical prosthetic weights (150 g versus 770 g versus 1625 g) to the prostheses of 10 participants with unilateral dysvascular transfemoral amputation. Eight participants were over 60 years of age. The trial found that four participants preferred the lightest weight (150 g), five preferred the middle weight (770 g) and one preferred the addition of the heaviest weight (1625 g). 1Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 4. Authors’ conclusions There is a lack of evidence from randomised controlled trials to inform the choice of prosthetic rehabilitation, including the optimum weight of prosthesis, after unilateral transfemoral amputation in older dysvascular people. A programme of research, including ran- domised controlled trials to examine key interventions, is urgently required in this area. P L A I N L A N G U A G E S U M M A R Y Artificial limb rehabilitation for older people with a leg amputated at or above the knee because of blood circulation problems Problems with inadequate circulation in the legs (dysvascularity), particularly in people over the age of 60 years, can be so severe that they need a leg amputated. This may be as high as at or above the knee. Accompanying medical conditions (co-morbidities) such as diabetes, cardiovascular or heart disease can affect a person’s rehabilitation. When an above or through knee artificial limb (prosthesis) is fitted, it is hard to regain mobility and function and some people choose to use a wheelchair. Motivation, comfort, cosmetic appearance, functionality, reliability, ease of use, previous mobility and the extra exertion needed to use an artificial leg are all potentially important factors that affect a person’s independence and their use of the prosthesis. Fear of falling, number of falls, social circumstances, help and support from other people are also important influences. The review authors searched for trials comparing different types of rehabilitation that may benefit the mobility or function in older people using an artificial limb. Only one controlled trial was found. This had a crossover design and each of the 10 participants had three seemingly identical prosthetic weights added to the prosthesis below the knee in a random order. The participants, nine men and one woman, were over 50 years of age and eight were over 60 years. Over the few hours of the trial, four participants preferred the lightest weight (150 g), five preferred the medium weight (770 g) and one preferred the heaviest weight (1625 g). Seven of the 10 people successfully ranked the weights from lightest to heaviest. The weights did not alter the participant’s walking speed in a two-minute walk test. The small number of participants, short exposure to the different weights in a laboratory setting and the fact that there were differences in weight between people and also their prosthesis limits the usefulness of these findings. The artificial limbs were all modular style prostheses. B A C K G R O U N D Each year, in excess of 6000 leg amputations are performed in the United Kingdom (UK) (ISD 2004); there were over 148,000 reported hospital discharges in 1996 for limb loss in the USA (LLRSP 2000). The number of amputees worldwide is not cur- rently tracked by any organization. The incidence of dysvascularity (poor circulation) increases with age and the presence of co-mor- bidities (other medical conditions) such as diabetes. In the UK, dysvascularity accounts for 75% of all lower limb amputations, of which 37% are transfemoral (through the thigh). Similarly, dys- vascularity accounts for 87% of all amputations in the USA. Following amputation of the lower limb, a prosthesis (artificial leg) is frequently prescribed. It is reported that older dysvascular unilateral transfemoral amputees do not achieve a high level of prosthetic mobility or function, particularly in comparison with transtibial (through the calf) amputees. However, success rates for prosthetic rehabilitation in this population differ markedly. A recent study found that only 25% of transfemoral amputees over the age of 50 years achieved community mobility and this figure reduced with advancing age (Davies 2003). In contrast an earlier study found that only 4% of this population were community ambulators (Houghton 1992). Some studies have attempted to identify factors that contribute to functional outcomes for amputees. These factors include psy- chological and social aspects, presence of co-morbidities and age. There has also been an attempt to use such factors to predict successful rehabilitation (Munin 2001). Clinical guidelines in the UK (Broomhead 2003) recommend that patients should be made aware that concurrent pathologies and previous mobility affect re- alistic goal setting and the outcomes of prosthetic rehabilitation. Success of prosthetic provision is frequently judged in terms of clinical measures of impairment or function, for example walking 45 m with the prosthesis (Munin 2001). However, the relationship between the amputee and their prosthesis is potentially more com- 2Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 5. plex, involving motivation, comfort, cosmetic appearance, func- tionality, reliability, ease of use and degree of energy expenditure during use. Transfemoral amputees have a greater level of disability and use 65% more energy than bipedal (normal) walking (Waters 1976). The prevalence of co-existing cardiovascular disease in pa- tients with dysvascular amputation may be as high as 75% and co- morbid heart disease may prevent patients from achieving maxi- mum functional independence (Roth 1998). Therefore, older dys- vascular transfemoral amputees with cardiac abnormalities may be at increased risk of an adverse event, such as heart failure, by being exercised during prosthetic rehabilitation. Patients referred to the 42 prosthetics (artificial limb) centres in Britain and Northern Ireland are assessed for physical and psy- chological capabilities by a multi-disciplinary team of healthcare professionals. Patients’ and carers’ wishes are taken into account. The outcome of the visit is a decision to prescribe a functional or cosmetic prosthesis or to recommend an alternative form of func- tional independence, for example a powered wheelchair. Under the UK’s National Health Service all older amputees are issued with a wheelchair for mobility as standard service. However, current UK clinical guidelines (Broomhead 2003) indicate that evidence underpinning the clinical decision path is sparse. Older people with a unilateral transfemoral amputation are an in- creasingly important subgroup of amputees that has been iden- tified as having a low success rate with a prosthesis, in terms of functional mobility and usage. Healthcare professionals involved in amputee rehabilitation require more evidence to support clin- ical decisions regarding a patient in this age group’s suitability for prosthetic rehabilitation, especially when patient expectations do not match clinical decisions. Furthermore, patients and carers have a right to good, evidence-based information on which to base their decisions regarding living either independently or with care in the community. This includes whether mobility or function will be achievable with a prosthesis, a wheelchair or a combination of both. It is a professional’s duty to discuss the advantages and disadvantages of each path and also to inform of any clinical risk. It is important to review interventions to improve rehabilitation prospects. Therefore, there was a need for a systematic review of the evidence relating to prosthetic rehabilitation in older dysvas- cular unilateral transfemoral amputees to inform clinical practice O B J E C T I V E S To identify and summarise the evidence from randomised con- trolled trials evaluating prosthetic rehabilitation interventions fol- lowing unilateral transfemoral or transgenicular amputation in older dysvascular people, whether community dwelling or insti- tutionalised. M E T H O D S Criteria for considering studies for this review Types of studies Randomised controlled trials (RCTs) and quasi-randomised tri- als (for example, randomised by date of birth or hospital record number) that evaluated the success of prosthetic rehabilitation fol- lowing a unilateral transfemoral amputation in older dysvascular people. Types of participants Male or female participants described as: • older adults, elderly, veteran, geriatric, aged, seniors or all over the age of 60 years; • living in the community or in institutional care; and • dysvascular; • having a unilateral transfemoral amputation, including transgenicular (through the knee) and provided with a transfemoral prosthesis for walking and functional rehabilitation. Participant characteristics of interest included age, gender, previ- ous level of mobility and co-morbidities. Types of interventions Prosthetic rehabilitation included the provision of a prescribed prosthesis postamputation that was suitable for the individual’s needs with the aim of achieving an optimum level of function and mobility following therapy intervention. Interventions that may form part of the prosthetic rehabilitation package included, but were not limited to: • education on how to safely put on and take off the prosthesis, dressing practice and footwear provision; • education on skin and residual skin care, hygiene of the prosthesis and socks, and fit of the prosthesis; • therapeutic interventions to increase muscle power, range of movement, improve core stability and optimise gait and control of the prosthesis; • balance and mobility training whilst wearing the prosthesis, including in different environments, negotiating hazards and getting up from a fall; • training in functional activities of daily living, including domestic activities; • general advice, e.g., where to seek help, aids, adaptations, driving, support groups and return to work. We included trials in which participants were randomised to re- ceive any combination of the following: usual care, a single therapy intervention or a multiple therapy intervention. Trials comparing two or more interventions were also to be included. The ther- apy interventions could take place in the home, an institutional 3Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 6. dwelling, the community, a gymnasium or clinic setting and could be self-supervised (for example, using exercise sheets or video), in- dividually supervised or given as part of a supervised group. Types of outcome measures The main outcome of interest was ’success’ as defined below. Out- come measures were classified according to the dimensions of the International Classification of Functioning, Disability and Health (ICF) (WHO 2001): impairment, activity limitation or partici- pation restriction. Primary outcomes The primary measure of success was user satisfaction based on comfort, cosmetic appearance, frequency of prosthetic use, sat- isfaction for purpose, levels of function and independence. Ac- ceptable measures or scales included: Prosthetic Socket Fit Com- fort Score, Harold-Wood Stanmore Mobility Grades, Locomotor Capabilities Index, Rivermead Mobility Index (RMI), Prosthe- sis Evaluation Questionnaire (PEQ), Satisfaction with Prosthesis (SATPRO), Functional Measure for Amputees and Russek’s Scale. Secondary outcomes Secondary outcome measures were general quality of life measures including, but not limited to, the Sickness Impact Profile, Not- tingham Health Profile and the MOS Short Form SF-36. Other variables of interest included: morbidity, mortality, com- pliance with rehabilitation, psychological distress (anxiety or de- pression, or both), discharge placement and wheelchair use, co- morbidities, indicators of previous level of mobility, number of falls experienced, problems associated with dysvascularity of the remaining limb, sensory impairment, falls risk, fear of falling, so- cial circumstances and level of support available or required. We intendedtoreportthe nature andnumberof any adverse events described in included studies. Search methods for identification of studies 2014 update searches For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Regis- ter (last searched July 2014) and the Cochrane Register of Stud- ies (CRS) (http://www.metaxis.com/CRSWeb/Index.asp) (last searched 2014 Issue 6) for publications describing randomised controlled trials of prosthetic rehabilitation for older dysvascu- lar people following a unilateral transfemoral amputation. See (Appendix 1) for details of the search strategy used to search the CRS. The Specialised Register is maintained by the TSC and is constructed from weekly electronic searches of MEDLINE, EM- BASE, CINAHL, AMED, and through handsearching relevant journals. The full list of the databases, journals and conference proceedings which have been searched, as well as the search strate- gies used are described in the (Specialised Register) section of the Cochrane Peripheral Vascular Diseases Group module in The Cochrane Library (www.thecochranelibrary.com). Previous searches For the original review we searched the database of the Cochrane Rehabilitation and Related Therapies Field (to December 2005), MEDLINE (January 1966 to January 2006), EMBASE (January 1980toJanuary2006),CINAHL(January1982 toJanuary2006), AMED (January 1985 to December 2005), PSYCINFO (January 1982 to December 2005) and ASSIA (Applied Social Science In- dex) (January 1987 to August 2005). We also searched, up to 21st December 2005, PEDro (The Physiotherapy Evidence Database at (http://www.pedro.fhs.usyd.edu.au/), OT Seeker (The Occu- pational Therapy Systematic Evaluation of Evidence Database at (http://www.otseeker.com), RECAL (specialist prosthetic and or- thotics database at University of Strathclyde, UK), BNI (British Nursing Index), and Rehab Base (National Rehabilitation In- formation Clearing House). We searched the UK National Re- search Register at (http://www.update-software.com/national/) (up to Issue 2, 2005) and Controlled Clinical Trials at (http:// www.controlled-trials.com) (accessed June 2005) for ongoing and recently completed trials. We inspected reference lists of articles, checked our reference databases and contacted experts in the field. No language restrictions were applied. In MEDLINE (OVID-WEB), three levels of the optimal trial search strategy developed by Robinson (Robinson 2002) were combined with the subject-specific search. See Appendix 2 for details of the search strategy used for MEDLINE and EMBASE (Datastar). Similar searches adapted for each database were run for CINAHL, AMED, PSYCINFO, BNI and ASSIA. Searches on the remaining databases, were based on a few key words (for example, AMPUTEE OR AMPUTATION) or specific categories within the individual databases. Key words included Physio*, Phys* therap*, AND Amput*, prosthe*, Lower limb OR lower extremity. Data collection and analysis Selecting trials for inclusion From the title, abstract and descriptors, two authors (JC and SB) independently reviewed the results of the literature searches to identify potentially relevant trials for full review. From the full text, trials that met the selection criteria were independently se- lected for inclusion by the same two authors. Any disagreement not resolved by consensus would have been put forward for third party adjudication by TH. 4Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 7. Data collection Two authors (JC and SB) independently extracted data using a customised data extraction tool that was tested prior to use. Con- tacting authors of studies was not necessary. Assessment of methodological quality Two authors (JC and SB) independently assessed 15 aspects of methodological quality using a scoring scheme (see Table 1) that included items from the Cochrane Bone, Joint and Muscle Trauma Group’s generic quality assessment scheme (denoted by ’M’), items from the Delphi list (denoted by ’D’) (Verhagen 1998) and items from the Maastricht-Amsterdam consensus list for Methodologi- cal Quality Assessment (denoted by ’MAC’) (Bellamy 1997). Any disagreement not resolved by consensus would have been put for- ward for third party adjudication by TH. Data analysis Where available and appropriate, we planned to present quanti- tative data for the outcomes listed in the inclusion criteria. We planned to present risk ratios and 95% confidence intervals for dichotomous outcomes, and mean differences and 95% confi- dence intervals for continuous outcomes. Where appropriate, we planned to pool results of comparable groups of trials using the fixed-effect model and 95% confidence intervals. Heterogeneity between comparable trials was to be tested using a standard chi- squared test and considered statistically significant at P < 0.1, after due consideration of the value of the I² result. If pooling were not possible we stipulated that appropriate or narrative description of results would be presented. Sensitivity and subgroup analyses We planned to perform sensitivity analyses, where indicated and appropriate, to investigate the effects of allocation concealment, methodological quality, and intention-to-treat analysis. Where the data allowed, we also planned separate outcome analyses to test the following hypotheses: • prosthetic rehabilitation is equally successful in males and females; • success does not depend on the duration and (or) intensity of prosthetic rehabilitation; • success does not depend on the setting in which the prosthetic rehabilitation is delivered; • success does not depend on the level or type of supervision of prosthetic rehabilitation. R E S U L T S Description of studies Results of the search 2014 update searches See Figure 1. 5Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 8. Figure 1. Study flow diagram. Previous searches The Cochrane Peripheral Vascular Diseases (PVD) Group pro- vided citations for 17 trials of which four were considered as po- tentially eligible. The MEDLINE search (January 1966 to 5th July 2005) yielded 1118 journal articles of which 12 were considered as potentially eligible. The EMBASE search (1980 to 10th August 2005) produced 319 journal articles of which 12 were considered as potentially eligible. The CINAHL search (1982 to 1st August 2005) produced 73 papers of which four were considered as potentially eligible. The PSYCINFO search (1982 to 4th August 2005) produced 705 hits of which five were considered as potentially eligible. We found no additional papers through searching AMED, ASSIA, PEDro, RECAL, BNI, OTseeker or Rehab base. We did not locate any ongoing or unpublished trials. Since the searches on the databases were run separately there was some duplication in the citations selected for retrieval of full re- ports. In all, we obtained the full reports of 38 studies. From these, five trials were selected for inclusion or exclusion in the main re- view. The only trial (Meikle 2003) suitable for inclusion appeared in the citations provided by the Cochrane Peripheral Vascular Dis- eases Group and in the MEDLINE and EMBASE searches. Included studies The only included study (Meikle 2003) was a crossover ran- domised trial which tested the effects of adding three seemingly identical prosthetic weights (150 g versus 770 g versus 1625 g) 6Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 9. in a randomised order to the prostheses of 10 amputees. All the participants had undergone transfemoral amputations for vascu- lar reasons. The mean age was 65 years although two participants were aged between 50 and 60 years. One participant was female. All participants were community ambulators, with at least three months since their amputation, and had similar activity levels. The study compared the effects of adding three different weights below the knee joint to each participant’s prosthesis during a single ses- sion. The primary outcome measure was participant preference, which was based on the rank order of preference of the participant for the three different weights. This was interpreted as equating to user satisfaction. The other main outcome measure of the trial was participant gait speed as measured by the two minute walk test (2MWT). This is a laboratory-based measure of mobility that does not satisfy the inclusion criteria of this review. Also investi- gated was the participant’s ability to identify the weight that had been added. See the Characteristics of included studies for summary details. Excluded studies Fourtrialswere excluded(Alexander1978; Godfrey1977; Presern- Strukel 2000; Wong 2002). See the Characteristics of excluded studies for summary details. Risk of bias in included studies See Table 2 for details of the quality assessment of the single in- cluded study (Meikle 2003). The interventions applied to each participant were in randomised order but the procedure of ran- domisation was not described. During the study, effective mea- sures were taken to blind both the assessor and the study partici- pants to each intervention, that is the weight added to the pros- thesis. There were no participant withdrawals as this was a sin- gle-session laboratory-based study with no follow up. The inclu- sion and exclusion criteria and participant characteristics were all clearly described. Effects of interventions Only one study was included (Meikle 2003). Of the 10 partici- pants in the trial four preferred the placebo weight (150 g), five preferred the 770 g weight and one preferred the 1625 g weight. Seven participants successfully ranked the weights from lightest to heaviest. Meikle 2003 reported there was no significant difference in participant gait speed with the addition of the three different weights to the prosthesis. The authors in this study used the term weight rather than the more correct mass to describe the additions to the prosthesis. The authors’ terminology has been retained in this review as it is more commonly used outside the scientific community. D I S C U S S I O N Older people with a unilateral transfemoral amputation are an increasingly important subgroup of amputees that is identified as having a low success rate with a prosthesis, in terms of functional mobility and usage. It is disappointing, therefore, that there is a paucity of good quality and reliable research evidence that can be used to inform clinical practice. Only one randomised trial satisfied the eligibility criteria for this review. This trial (Meikle 2003) was judged to be of moderate methodological quality and hence the results should be interpreted with caution. A deficiency of evidence may also apply to other transfemoral amputee groups as only one randomised controlled trial was identified investigating the effects of a therapeutic inter- vention within prosthetic rehabilitation in young traumatic trans- femoral amputees (Yigiter 2002). Although the weight of an amputee’s prosthetic limb is clinically important, particularly from the point of view of amputee sat- isfaction, the included study provided only minimal evidence of effect. Indeed, the small number of participants, limitations of the crossover design, the short duration of the intervention, the lab- oratory nature of the trial, the absence of follow up and limited nature of outcome assessment prevent such a trial from providing adequate evidence to inform the prescription of prosthetic limbs. As acknowledged by the trial authors, the most the trial results do is to challenge an assumption, if made, that patients will always prefer the lightest prosthesis. Even this assertion needs to be seen in the context of the very short-term nature of the intervention (a few hours). Other issues also merit consideration. The interven- tions in this study were all identical (weight added to a prosthesis) and were absolute values that were identical between participants. However, the body weight of the individual participants varied from 52 kg to 112 kg and thus the relative mass (weight) was dif- ferent between participants. The pre-intervention weight of the prosthesis used by each participant also differed, from 2.8 to 4.2 kg. Therefore, in both cases the perceived weight that was added to the prosthesis may have been different. Participants were only permitted 5 to 10 minutes to familiarise themselves with the new prosthetic weight before taking the walk test. It may have been that in this population participants would have benefited from a longer period to acclimatise to the added weight of the prosthetic limb. Participants used their own prosthetic limbs; these were all en- doskeletal prostheses with modified quadrilateral sockets and the same types of suspension. However, the knee and foot prosthetic components were not standardised between participants. These factors, either individually or in combination, could potentially confound the results of this study. The authors (Meikle 2003) also acknowledge the difficulties in performing trials in rehabilitation where the question and the interpretation of the findings may not be quite as straightforward as they initially appear. Certainly, research on the optimum weight of a prosthetic limb 7Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 10. in this population would be useful. Such research should include assessment of the known high energy expenditure costs that older unilateral dysvascular transfemoral amputees experience in the presence of co-morbidities. A much larger sample size, standardis- ation of prosthetic components, randomisation into separate treat- ment groups, longer trial duration and appropriate follow up may provide the necessary clinically relevant data on the optimum weight of a prosthetic limb for this population. A U T H O R S ’ C O N C L U S I O N S Implications for practice There is a lack of evidence from randomised controlled trials to inform the choice of prosthetic rehabilitation, including the op- timum weight of a prosthesis, after unilateral transfemoral ampu- tation in older dysvascular people. Implications for research Most of the research in this area of clinical practice has been through cohort studies based upon prognostic indicators of suc- cess. These have included psychological and cognitive aspects, co- morbidities, functional abilities, compliance and the use of assess- ment tools. This is not enough to inform practice. There is an ur- gent need for reliable evidence from high quality and sufficiently powered randomised controlled trials on the success (for exam- ple, user satisfaction based on comfort, cosmetic appearance, fre- quency of prosthetic use, satisfaction for purpose, levels of func- tion and independence) of key prosthetic rehabilitation interven- tions following transfemoral amputation in older dysvascular peo- ple. Research topic priorities informed by clinicians and amputees need to be ascertained beforehand in order to set up a research programme to address the important questions in this clinical area. A C K N O W L E D G E M E N T S We would like to thank Julie Hogg, University of Teesside, Mid- dlesbrough for her assistance with developing the search strategies for a number of the databases in the original review; and Heather Smart, The National Centre for Education and Training in Pros- thetics and Orthotics for developing the RECAL search strategy for the original review. We are also grateful to the Cochrane Col- laborative Review Group on Peripheral Vascular Diseases for their help and patience and to the Cochrane Consumer Network for updating the Plain Language Summary in the previous review. We thank Helen Handoll and Keith Rome, Teesside Centre for Reha- bilitation Science, Middlesbrough, for their encouragement and helpful discussions on rehabilitation research. R E F E R E N C E S References to studies included in this review Meikle 2003 {published data only} Meikle B, Boulias C, Pauley T, Devlin M. Does increased prosthetic weight affect gait speed and patient preference in dysvascular transfemoral amputees?. Archives of Physical Medicine and Rehabilitation 2003;84(11):1657–61. [: CN–00453251] References to studies excluded from this review Alexander 1978 {published data only} Alexander J, Goodrich R. Videotape immediate playback: a tool in rehabilitation of persons with amputations. Archives of Physical Medicine and Rehabilitation 1978;59(3):141–4. Godfrey 1977 {published data only} Godfrey CM, Brett R, Jousse AT. Foot mass and effect on gait in the prosthetic limb. Archives of Physical Medicine and Rehabilitation 1977;586(6):268–9. Presern-Strukel 2000 {published data only} Presern-Strukelj M, Poredos P. The influence of electrostimulation on the circulation of the remaining leg in patients with one-sided amputation. Angiology 2002;53(3): 329–35. Wong 2002 {published data only} Wong CK, Edelstein JE. Unna and elastic post operative dressings: Comparison of their effects on function of adults with amputation and vascular disease. Archives of Physical Medicine and Rehabilitation 2000;81(9):1191–8. Additional references Bellamy 1997 Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al.Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis: Consensus development at OMERACT III. Journal of Rheumatology 1997;24(4):799–802. Broomhead 2003 Broomhead P, Dawes D, Lambert A, Shepherd R, Quinlivan D. Evidence based Clinical Guidelines for the Physiotherapy Management of Adults with Lower Limb Prostheses. Chartered Society of Physiotherapy. London, 2003. Davies 2003 Davies B, Datta D. Mobility outcome following unilateral lower limb amputation. Prosthetics and Orthotics International 2003;27(3):186–90. 8Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 11. Houghton 1992 Houghton AD, Taylor PR, Thurlow S, Rootes E, McColl. Success rates for rehabilitation of vascular amputees: implications for preoperative assessment and amputation level. British Journal of Surgery 1992;79(8):753–5. ISD 2004 Information and Statistics Division NHS Scotland. The amputee statistical database for the United Kingdom 2002/ 03. http://www.nasdab.co.uk/pdf.pl?file=nasdab/news/ Intro.pdf (accessed 12 October 2004). LLRSP 2000 Limb Loss Research and Statistics Program. Estimates of incidence (rate) of limb loss and congenital limb absence in the United States. http://www.amputee-coalition.org/ llrsp˙update/llrsp˙update˙2000.html (accessed 18 August 2004). Munin 2001 Munin MC, Espejo-De Guzman MC, Boninger ML, Fitzgerald SG, Penrod LE, Singh J. Predictive factors for successful early prosthetic ambulation among lower- limb amputees. Journal of Rehabilitation Research and Development 2001;38(4):379–84. Robinson 2002 Robinson KA, Dickerson K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. International Journal of Epidemiology 2002;31(1):150–3. Roth 1998 Roth EJ, Park KL, Sullivan WJ. Cardiovascular disease in patients with dysvascular amputation. Archives of Physical Medicine and Rehabilitation 1998;79(2):205–15. Verhagen 1998 Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, et al.The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. Journal of Clinical Epidemiology 1998;51(12):1235–41. Waters 1976 Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of walking of amputees: the influence of level of amputation. Journal of Bone and Joint Surgery 1976;58(1):42–6. WHO 2001 World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organisation, 2001. [: ISBN 9241545429. m] Yigiter 2002 Yigiter K, Sener G, Erbahceci F, Bayer K, Ulger OG, Akdogan S. A comparison of traditional prosthetic training versus propioceptive neuromuscular facilitation resistive gait training with trans-femoral amputees. Prosthetics and Orthotics International 2002;26:213–7. References to other published versions of this review Cumming 2006 Cumming J, Barr S, Howe TE. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation. Cochrane Database of Systematic Reviews 2006, Issue 4. [DOI: 10.1002/14651858.CD005260.pub2] Howe 2005 Howe TE, Cumming JCO, Barr S. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation. Cochrane Database of Systematic Reviews 2005, Issue 2. [DOI: 10.1002/ 14651858.CD005260] ∗ Indicates the major publication for the study 9Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 12. C H A R A C T E R I S T I C S O F S T U D I E S Characteristics of included studies [ordered by study ID] Meikle 2003 Methods Study design: Single-centre, randomised, double blind crossover trial Exclusions post randomisation: None. Losses to follow up: Of 12 participants that were eligible for the study, 2 refused to partic- ipate Participants Country: Canada. Setting: Community. No. of participants: 10. Inclusion criteria: Loss of limb due to peripheral vascular disease; over the age of 50; ambulant in the community for minimum of 3 months since amputation; independent community ambulator with prosthesis with or without aids; ability to walk for 2 minutes consecutively Exclusion criteria: Cognitive impairment sufficient to limit ability to participate Interventions Single session assessment. Added weight to prosthetic limb below the knee: 150 g (placebo) versus 770 g versus 1625 g Duration: One day. Follow up: None - single assessment only. Outcomes Primary: 2 minute walk test. Secondary: Participant preference in terms of weight applied Notes No follow up following trial period. Risk of bias Bias Authors’ judgement Support for judgement Allocation concealment (selection bias) Unclear risk B - Unclear Characteristics of excluded studies [ordered by study ID] Study Reason for exclusion Alexander 1978 Only two transfemoral amputees in trial. Inadequate randomisation Godfrey 1977 Inadequate randomisation described and no participant demographics Presern-Strukel 2000 Outcome measures used in this trial did not meet the outcomes selected for this review 10Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 13. (Continued) Wong 2002 Pre-prosthetic rehabilitation intervention which falls out of the scope of this review 11Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 14. D A T A A N D A N A L Y S E S This review has no analyses. A D D I T I O N A L T A B L E S Table 1. Quality assessment items and possible scores Items and scores M-A (D1b). Was the assigned treatment adequately concealed prior to allocation? 2 = method did not allow disclosure of assignment. 1 = small but possible chance of disclosure of assignment or unclear. 0 = quasi-randomised or open list/tables. Cochrane code: Clearly Yes = A; Not sure = B; Clearly No = C M-B (D8). Were the outcomes of withdrawn participants described and included in the analysis (intention to treat)? 2 = withdrawals well described and accounted for in analysis. 1 = withdrawals described and analysis not possible. 0 = no mention, inadequate mention, or obvious differences and no adjustment M-C (D4). Were the outcome assessors blinded to treatment status? 2 = effective action taken to blind assessors. 1 = small or moderate chance of unblinding of assessors. 0 = not mentioned or not possible. M-D (D2). Were the treatment and control groups comparable at entry? 2 = good comparability of groups, or confounding adjusted for in analysis. 1 = confounding small; mentioned but no adjustment made. 0 = large potential for confounding, or not discussed. M-E (D6). Were the participants blind to assignment status after allocation? 2 = effective action taken to blind participants. 1 = small or moderate chance of unblinding of participants. 0 = not possible, or not mentioned (unless double-blind), or possible but not done M-F (D5). Were the treatment providers blind to assignment status? 2 = effective action taken to blind treatment providers. 1 = small or moderate chance of unblinding of treatment providers. 0 = not possible, or not mentioned (unless double-blind), or possible but not done M-G. Were care programmes, other than the trial options, identical? 2 = care programmes clearly identical. 1 = clear but trivial differences. 0 = not mentioned or clear and important differences in care programmes M-H (D3). Were the inclusion and exclusion criteria clearly defined? 2 = clearly defined. 1 = inadequately defined. 12Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 15. Table 1. Quality assessment items and possible scores (Continued) 0 = not defined. M-I. Were the interventions clearly defined? 2 = clearly defined interventions are applied with a standardised protocol. 1 = clearly defined interventions are applied but the application protocol is not standardised. 0 = intervention and/or application protocol are poorly or not defined M-J. Were the outcome measures used clearly defined? 2 = clearly defined. 1 = inadequately defined. 0 = not defined. M-K. Were tests used in outcome assessment clinically useful? 2 = optimal. 1 = adequate. 0 = not defined, not adequate. M-L. Was the surveillance active, and of clinically appropriate duration (i.e. at least 3 months)? 2 = active surveillance and appropriate duration (3 months follow up or more). 1 = active surveillance, but inadequate duration (less than 3 months follow up). 0 = surveillance not active or not defined. D7. Were point estimates and measures of variability presented for the primary outcome measures? 2 = yes. 1 = point estimates, but no measures of variability presented. 0 = vague descriptions. MAC-1. Was the compliance rate in each group likely to cause bias? 2 = compliance well described and accounted for in analysis. 1 = compliance well described but differences between groups not accounted for in analysis. 0 = compliance unclear. MAC-2. Was there a description of adverse effects of the intervention(s)? 2 = well described. 1 = poorly described. 0 = not described. Table 2. Quality assessment of included study Items Scores Was the assigned treatment adequately concealed prior to alloca- tion? 0 Were the outcomes of withdrawn participants described and in- cluded in the analysis (intention to treat)? 0 Were the outcome assessors blinded to treatment status? 2 13Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 16. Table 2. Quality assessment of included study (Continued) Were the treatment and control groups comparable at entry 2 Were the participants blind to assignment status after allocation? 1 Were the treatment providers blind to assignment status? 2 Were care programmes, other than trial options, identical? 2 Were the inclusion and exclusion criteria clearly defined? 2 Were the interventions clearly defined? 2 Were the outcome measures used clearly defined? 2 Were tests used in outcome assessment clinically useful? 1 Was the surveillance active, and of clinically appropriate duration (i.e. at least 3 months)? 0 Were point estimates and measures of variability presented for the primary outcome measures? 0 Was the compliance rate in each group likely to cause bias? 0 Was there a description of adverse effects of the intervention(s)? 0 A P P E N D I C E S Appendix 1. CRS search strategy #1 MESH DESCRIPTOR Arteriosclerosis 863 #2 MESH DESCRIPTOR Arteriolosclerosis EXPLODE ALL TREES 0 #3 MESH DESCRIPTOR Arteriosclerosis Obliterans 69 #4 MESH DESCRIPTOR Atherosclerosis 475 #5 MESH DESCRIPTOR Arterial Occlusive Diseases 694 14Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 17. (Continued) #6 MESH DESCRIPTOR Intermittent Claudication 661 #7 MESH DESCRIPTOR Ischemia 712 #8 MESH DESCRIPTOR Peripheral Vascular Diseases EX- PLODE ALL TREES 2060 #9 (atherosclero* or arteriosclero* or PVD or PAOD or PAD ): TI,AB,KY 6830 #10 ((arter* or vascular or vein* or veno* or peripher*) near3 (oc- clus* or reocclus* or re-occlus* or steno* or restenos* or ob- struct* or lesio* or block* or harden* or stiffen* or obliter*) ): TI,AB,KY 5524 #11 (peripheral near3 dis*):TI,AB,KY 2486 #12 (claudic* or IC):TI,AB,KY 2230 #13 (isch* or CLI):TI,AB,KY 16857 #14 arteriopathic:TI,AB,KY 7 #15 dysvascular*:TI,AB,KY 8 #16 (leg near3 (occlus* or reocclus* or re-occlus* or steno* or restenos* or obstruct* or lesio* or block* or harden* or stiffen* or obliter*) ):TI,AB,KY 68 #17 (limb near3 (occlus* or reocclus* or re-occlus* or steno* or restenos* or obstruct* or lesio* or block* or harden* or stiffen* or obliter*) ):TI,AB,KY 92 #18 ((lower near3 extrem*) near3 (occlus* or reocclus* or re-oc- clus* or steno* or restenos* or obstruct* or lesio* or block* or harden* or stiffen* or obliter*) ):TI,AB,KY 63 #19 ((iliac or femoral or popliteal or femoro* or fempop* or crural) near3(occlus* or reocclus* or re-occlus* or steno* or restenos* or obstruct* or lesio* or block* or harden* or stiffen* or obliter*) ):TI,AB,KY 641 #20 MESH DESCRIPTOR Leg EXPLODE ALL TREES WITH QUALIFIERS BS 1061 #21 MESH DESCRIPTOR Iliac Artery 135 #22 MESH DESCRIPTOR Popliteal Artery 246 15Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 18. (Continued) #23 MESH DESCRIPTOR Femoral Artery 718 #24 MESH DESCRIPTOR Tibial Arteries 30 #25 (((femor* or iliac or popliteal or fempop* or crural or poplite* or infrapopliteal or inguinal or femdist* or inguinal or infrain- quinal or tibial) near3 (occlus* or reocclus* or re-occlus* or steno* or restenos* or obstruct* or lesio* or block* or harden* or stiffen* or obliter*) )):TI,AB,KY 752 #26 MESH DESCRIPTOR Gangrene EXPLODE ALL TREES 62 #27 MESH DESCRIPTOR Diabetic Angiopathies EXPLODE ALL TREES 1852 #28 gangren*:TI,AB,KY 235 #29 (diabet* near3 angio*):TI,AB,KY 958 #30 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 34061 #31 MESHDESCRIPTORAmputationEXPLODEALLTREES 266 #32 MESH DESCRIPTOR Amputees EXPLODE ALL TREES 66 #33 (leg near3 amput*):TI,AB,KY 42 #34 (extrem* near3 amput*):TI,AB,KY 57 #35 (limb near3 amput*):TI,AB,KY 124 #36 exarticulat*:TI,AB,KY 0 #37 disarticulat*:TI,AB,KY 11 #38 transgeni*:TI,AB,KY 97 #39 #31 OR #32 OR #33 OR #34 OR #35 OR #36 OR #37 OR #38 547 #40 MESH DESCRIPTOR Artificial Limbs 89 #41 MESH DESCRIPTOR Joint Prosthesis EXPLODE ALL TREES 1448 16Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 19. (Continued) #42 prosthe*:TI,AB,KY 7116 #43 (artificial near3 (leg or limb or low or extremity)):TI,AB,KY 19 #44 MESH DESCRIPTOR Rehabilitation EXPLODE ALL TREES 13035 #45 rehabilit*:TI,AB,KY 19004 #46 #40 OR #41 OR #42 OR #43 OR #44 OR #45 33733 #47 #30 AND #39 AND #46 55 Appendix 2. Search strategies for MEDLINE (OVID-WEB) and EMBASE (Datastar) MEDLINE (OVID-WEB) EMBASE (Datastar) 1 randomized controlled trial.pt. 2 controlled clinical trial.pt. 3 randomized controlled trials.sh. 4 random allocation.sh. 5 double blind method.sh. 6 single blind method.sh. 7 or/1-6 8 (animals not human).sh. 9 7 not 8 10 clinical trial.pt. 11 exp Clinical Trials/ 12 (clin$ adj25 trial$).ab,ti. 13 ((singl$ or doubl$ or trebl$) adj25 (blind$ or mask$)).ab,ti. 14 placebo$.sh. 15 placebo$.ab,ti. 1 RANDOMIZED-CONTROLLED-TRIAL#.DE. 2 CLINICAL-TRIAL#.DE. 3 RANDOMISED-CONTROLLED-TRIAL.MJ. 4 RANDOMISATION.W.MJ. 5 DOUBLE-BLIND-PROCEDURE.MJ. 6 SINGLE-BLIND-PROCEDURE.MJ. 7 1 OR 2 OR 3 OR 4 OR 5 OR 6 8 ANIMAL.W..MJ. 9 8 NOT HUMAN 10 7 NOT 9 11 CLINICAL-TRIAL#.DE. 12 CLINICAL-TRIAL.MJ. 13 (SINGLE OR DOUBLE OR TREBLE) ADJ (BLIND$2 OR MASK$3) 14 PLACEBO.W..MJ. 15 PLACEBO#.W..DE. 16 random$.ab,ti. 17 research design.sh. 18 or/10-17 19 18 not 8 20 19 not 9 21 comparative study.sh. 22 exp evaluation studies/ 23 follow up studies.sh. 24 prospective studies.sh. 25 (control$ or prospectiv$ or volunteer$).ab,ti. 26 or/21-25 27 26 not 8 16 RANDOM$4.TI. 17 RANDOM$4.AB. 18 METHODOLOGY.W..MJ. 19 OR/11-18 20 18 NOT 9 21 19 NOT 10 22 COMPARATIVE-STUDY.MJ. 23 EVALUATION.W..MJ. 24 EVALUATION#.W..DE. 25 FOLLOW-UP.MJ. 26 PROSPECTIVE STUDY.MJ. 17Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 20. (Continued) 28 27 not (9 or 20) 29 9 or 20 or 28 30 exp amputation/ 27 (CONTROL$3 OR PROSPECTIVE OR VOLUNTEER$3) .AB. 28 (CONTROL$3 OR PROSPECTIVE OR VOLUNTEER$3) .TI. 29 OR/22-28 30 29 NOT 9 31 amput$.mp. 32 exp amputees/ 33 30 or 31 or 32 34 exp artificial limbs/ 35 exp artificial leg/ 36 prosthe$.mp. 37 34 or 35 or 36 38 exp rehabilitation/ or exp rehabilitation nursing/ or exp reha- bilitation centers/ or exp rehabilitation, vocational/ 39 exp exercise therapy/ or exp exercise/ or exp exercise test/ or exp exercise movement techniques/ or exp exercise tolerance/ 40 exp “physical education and training”/ 41 exp physical therapy techniques/ 42 exp physical fitness/ 43 exp movement/ or exp exercise movement techniques/ 44 exp gait/ 45 exp locomotion/ 31 30 NOT 10 32 10 OR 21 OR 31 33 AMPUTATION#.W..DE. 34 AMPUTATION.W..MJ. 35 AMPUT$ 36 DISABLED-PERSON#.DE. 37 OR/33-36 38 LIMB-PROSTHESIS#.DE. 39 PROSTHE$ 40 ARTIFICIAL ADJ LIMB 41 OR/38-40 42 REHABILITATION#.W..DE. OR REHABILITATION- CENTER#.DE. OR REHABILITATION-MEDICINE#DE. OR NURSING#.W..DE. 43 KINESIOTHERAPY#.W..DE. 44 EX- ERCISE#.W..D DYNAMIC-EXERCISE#.DE. OR EXERCISE- ELECTROCARDIOGRAPHY#.DE. OR ERGOMETRY#.W.. DE. OR ISOKINETIC-EXERCISE#.DE. OR STATIC-EXER- CISE#.DE. OR EXERCISE-TEST#.DE. OR EXERCISE TOL- ERANCE#.DE. 45 PHYSIOTHERAPY#.W..DE. 46 exp walking/ 47 exp musculoskeletal equilibrium/ 48 exp contracture/ or exp posture/ or exp movement/ 49 exp exertion/ or exp muscle, skeletal/ or exp muscle contrac- tion/ or exp muscles/ or exp leg/ or exp isometric contraction/ 50 exp weight bearing/ 51 exp weight perception/ 52 exp biomechanics/ 53 exp energy metabolism/ or exp energy intake/ 54 exp efficiency/ 55 exp kinetics/ 56 or exp muscles/ or exp tarsal joints/ or exp ankle/ or exp elec- tromyography/ or exp kinesiology, applied/ or exp foot/ 57 (patient adj satisfaction).mp. 58 exp physician’s practice patterns/ or exp practice guidelines/ 59 exp clinical protocols/ 60 exp treatment outcome/ 46 TRAINING#.W..DE. 47 PHYSICAL-CAPACITY#.DE. OR PHYSICAL-AC- TIVITY#.DE. OR PHYSICAL-ACTIVITY-CAPACITY-AND- PERFORMANCE#.DE. OR COMPLIANCE-PHYSICAL#. DE. OR PHYSICAL-DISABILITY#.DE. OR PHYSICAL-ED- UCATION#.DE. OR PHYSICAL-STRESS#.DE. OR FIT- NESS#.W..DE. OR IMMOBILIZATION#.W..DE. OR PHYS- ICAL-MEDICINE#.DE. OR PHYSICAL-PERFORMANCE#. DE. OR PHYSICAL-RESISTANCE#.DE. OR PHYSIOTHER- APIST#.W..DE. 48 MOVEMENT-PHYSIOLOGY#.DE. OR LEG-MOVE- MENT#.DE. OR PASSIVE-MOVEMENT#.DE. OR MOVE- MENT-PERCEPTION#.DE. OR MOTION#,W..DE. OR MOVEMENT THERAPY#.DE. 49 GAIT#.W..DE. OR GAIT-DISORDER#.DE. 50 LOCOMOTION#.W..DE. 51 WALKING#.W..DE. OR WALKING-AID#.DE. OR WALKING-SPEED#.DE. 52 JOINT-MOBILITY#.DE. OR PATIENT-MOBILITY#.DE. 18Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 21. (Continued) 53 BALANCE-DISORDER#.DE. 54 BODY-EQUILIBRIUM#.DE. 55 CONTRACTURE#.W..DE. OR JOINT-CONTRAC- TURE#.DE. OR HIP-CONTRACTURE#.DE. 56 BODY-POSTURE#.DE. 57 MOVEMENT-PHYSIOLOGY#.DE. OR MOVEMENT- PERCEPTION#DE. ORLEG-MOVEMENT#.DE. ORLIMB- MOVEMENT#DE. OR PASSIVE-MOVEMENT#.DE. OR MOVEMENT-THERAPY#.DE. 58 WEIGHT-BEARING#.DE. 59 BIOMECHANICS#.W..DE. 60 ENERGY#.W..DE. OR ENERGY- BALANCE#.DE. OR ENERGY-CONSERVATION#.DE. OR ENERGY-CONSUMPTION#.DE. OR ENERGY-COST#.DE 61 exp aptitude/ 62 exp feedback/ 63 or/38-62 64 29 and 33 and 37 and 63 61 KINETICS#.W..DE. 62 PATIENT-SATISFACTION#.DE. 63 TREATMENT-OUTCOME#.DE. 64 APTITUDE#.W..DE. 65 MOTOR-PERFORMANCE#.DE. OR PHYSICAL PER- FORMANCE#.DE. 66 OR/42-65 67 32 AND 37 AND 41 AND 66 W H A T ’ S N E W Last assessed as up-to-date: 28 July 2014. Date Event Description 11 December 2014 New search has been performed New searches run. No new included studies. Minor text changes made 11 December 2014 New citation required but conclusions have not changed New searches run. No new included studies. No change to conclusions 19Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 22. H I S T O R Y Protocol first published: Issue 2, 2005 Review first published: Issue 4, 2006 Date Event Description 4 October 2010 New search has been performed CENTRAL search was amended and re-run and no new trials found 28 October 2008 New search has been performed Searches re-run and no new trials found. 23 May 2008 Amended Converted to new review format. 30 April 2007 Amended Minor copy edit to correct incomplete last sentence in authors conclusions and to correct Acknowledgements. Updated search dates. No changes to con- clusions C O N T R I B U T I O N S O F A U T H O R S JC conceived the review and designed the protocol with TH and SB. JC and SB provided and wrote the content-specific and clinical aspects of the protocol. TH co-ordinated the protocol development, including devising the quality assessment scheme, completed the draft protocol and with JC secured funding. JC and SB developed the revised search strategies at the review stage, ran these and sifted through the search results; they obtained copies of the trial reports, performed study selection, reviewed the included trial and produced the first and successive drafts of the review. TH continued to guide the review process and provided critical feedback. JC and SB are the guarantors of the review. D E C L A R A T I O N S O F I N T E R E S T SB: Received small grant from Physiotherapy Research Fund which assisted with some expenses associated with undertaking the review JC: Received small grant from Physiotherapy Research Fund and Health Foundation which assisted with expenses associated with undertaking the review, including review writing and expenses for travel and accommodation for presentation at the International Society of Prosthetics and Orthotics 2007 and Physiotherapy Congress 2008 TH: None known S O U R C E S O F S U P P O R T 20Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
  • 23. Internal sources • University of Teesside, UK. • South Tees Hospitals NHS Trust, James Cook University Hospital, Middlesbrough, UK. • Glasgow Caledonian University, Glasgow, UK. External sources • Health Foundation, London, UK. • The Physiotherapy Research Foundation of the Chartered Society of Physiotherapy (Charitable Trust), London, UK. • Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK. The PVD Group editorial base is supported by the Chief Scientist Office. I N D E X T E R M S Medical Subject Headings (MeSH) ∗Artificial Limbs [psychology]; Amputation [methods; ∗rehabilitation]; Femur [∗surgery]; Leg [blood supply; surgery]; Patient Satis- faction MeSH check words Aged; Humans; Middle Aged 21Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.