Background
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 occur as high as at or above the knee. Accompanying medical conditions (comorbidities) such as diabetes and cardiovascular or heart disease can affect a person's rehabilitation. When an above- or through-knee artificial limb (prosthesis) is fitted, it is hard for the person 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 important factors that can affect a person's independence and use of the prosthesis. Fear of falling, number of falls, social circumstances, and help and support from other people are also important influences. The review authors searched for trials comparing different types of rehabilitation that may benefit mobility or function in older people using an artificial limb.
Study characteristics and key results
Reviewers found only one controlled trial of moderate methodological quality (most recent search, 14 June 2018). This trial had a cross-over design, and each of the 10 participants had three seemingly identical prosthetic weights added to the prosthesis below the knee in random order. All artificial limbs were modular-style prostheses. The participants - nine men and one woman - were over 50 years of age, and eight were over 60 years old. 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 participants' walking speed in a two-minute walk test. Study authors reported no adverse effects.
Quality of the evidence and conclusions
The inclusion of only one trial with a small number of participants, short exposure to different weights in a laboratory setting, and the fact that there were differences in weight between people and their prostheses limit the usefulness of these findings. The limited evidence included in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people.
The limited evidence presented in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including the optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people. A programme of research that includes randomised controlled trials to examine key interventions is urgently required in this area.
Dysvascularity accounts for 75% of all lower limb amputations in the UK. Around 37% of these procedures are done at the transfemoral level (mid-thigh), with most patients over the age of 60 and having existing comorbidities. A significant number of these amputees are prescribed a lower limb prosthesis for walking. However, many amputees do not achieve a high level of function following prosthetic rehabilitation. This is the third update of the review first published in 2005.
To identify and summarise the evidence evaluating prosthetic rehabilitation interventions for prosthetic ambulation following unilateral transfemoral or transgenicular amputation in older dysvascular people, whether community dwelling or institutionalised.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register and CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials registry to 14 June 2018. We performed additional searches by handsearching citations of studies identified by the electronic search. We applied no restrictions on language or publication status.
Randomised and quasi-randomised controlled trials testing prosthetic rehabilitation interventions following a unilateral transfemoral or transgenicular amputation in older (aged 60 years or older) dysvascular people.
Two review authors independently scanned the search results for potentially eligible studies and, on obtaining full reports of these, selected studies for inclusion and exclusion. Two review authors independently assessed the methodological quality of studies and extracted data. We used GRADE to assess the overall quality of evidence supporting the outcomes assessed in this review.
We identified no new studies for inclusion in this update. In total we included one trial, excluded 18 trials, classed one trial as ongoing, and classed another as awaiting classification. The total number of participants in the included trial was 10, and the methodological quality of this trial was moderate because of high risk of bias in relation to two domains (random sequence generation and allocation concealment) but low risk of bias for the four remaining domains (blinding, incomplete outcome data, selective reporting, and any other bias). The included trial was a short-term cross-over randomised trial undertaken in Canada, which tested the effects of adding three seemingly identical prosthetic weights (150 g vs 770 g vs 1625 g) to the prostheses of a total of 10 participants with unilateral dysvascular transfemoral amputation. Eight participants were over 60 years of age. Trial authors found that four participants preferred the addition of the lightest weight (150 g), five preferred the middle weight (770 g), and one preferred the heaviest weight (1625 g). Researchers interpreted this as equating to user satisfaction (success) and reported no adverse effects.