Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 6, 2023
Date Accepted: Dec 10, 2023
Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals with Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multi-Site Clinical Trial
ABSTRACT
Background:
Powered ankle-foot prosthetic devices can generate net positive mechanical work during gait, which mimics the physiological ankle. However, gait deviations can persist for individuals with transfemoral limb loss, due to habit or lack of rehabilitation. Prosthetic research efforts favor the design or evaluation of prosthetic componentry and rarely incorporate any type of rehabilitation despite evidence suggesting it is critical for minimizing gait imbalances. Given the accelerated rate of innovation in prosthetics, there is a fundamental knowledge gap concerning how individuals with transfemoral limb loss should learn to correctly use powered ankle-foot devices for maximum functional benefit.
Objective:
The overarching goal of this investigation is to examine the roles of advanced prosthetic technology and a device-specific rehabilitative intervention for individuals with transfemoral limb loss.
Methods:
This investigation is a prospective, multisite study targeting enrollment of 30 individuals with unilateral transfemoral limb loss. At baseline, participants will undergo a full gait analysis and assessments for function, neurocognition, cognitive load, and pain using their current passive prosthesis. Participants will then be fitted with a powered ankle-foot device and randomized into 2 equal groups: Powered device with a device-specific rehabilitation intervention (Group A) or powered device with the current standard of practice (Group B). Group A will undergo 4 weeks of device-specific rehabilitation. Group B will receive the current standard of practice, which includes basic device education. Data collection procedures will then be repeated after 4- and 8-weeks of powered ankle use.
Results:
This study was funded in September 2017. Enrollment began in September 2018. Data collection will conclude by March 2024. Initial dissemination of results is expected in August 2024.
Conclusions:
Identifying potential mechanisms for correcting gait asymmetries, either through advanced prosthetic technology and/or rehabilitative interventions can provide a benchmark to understand optimal treatment strategies for individuals with transfemoral limb loss. Clinical Trial: ClinicalTrials.gov Identifier: NCT03625921; https://clinicaltrials.gov/study/NCT03625921
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