Testing and evaluation of lower limb prosthesis prototypes in people with a transfemoral amputation: a scoping review on research protocols.
Vera G M Kooiman, Eline S van Staveren, Ruud A Leijendekkers and 4 others
PMID 36635703WHAT IT FOUND
Testing of new above-knee prostheses lacks standard methods, with wide variation in participant selection, familiarization time, and outcome measures.
This prevents clinicians from comparing the real-world benefits of different prototype devices or assessing if they improve daily walking.
Key findings
01There is no standardized method for evaluating pre-commercial transfemoral prosthesis prototypes, leading to large variations in testing protocols and outcome measures that hinder comparison.
02The included studies heavily favored young, active, male participants with traumatic amputations, who are not representative of the wider amputation population.
03Mobility was the primary focus of most studies, yet a large portion of stated development aims had no corresponding outcome measures, and many outcome measures could not be linked to any specific aim.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The review included only studies published in English. The categorization of aims and outcome measures was based on self-defined categories by the authors, as no established framework existed. The correspondence between aims and outcome measures often had to be inferred by reviewers because justification was not always provided in the original articles. The review did not assess the methodological quality or risk of bias of the included studies. Search was limited to 2000-2020 to avoid obsolete technologies.
Declared interests
Funding was provided by Horizon 2020 and the Nederlandse Organisatie voor Wetenschappelijk Onderzoek (Dutch Research Council).
The easy way to misread this
Do not interpret the lack of standardized outcome measures as evidence that these prototypes are ineffective. The review highlights a methodological gap in how research is conducted, not the clinical utility of the devices themselves. Additionally, do not assume findings from these studies apply to your older or less active patients, as the study populations were predominantly young, active males with traumatic amputations.