About this trial
The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are:
* Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral transtibial amputation;
At least 6 months post-amputation;
A comfortable-fitting prosthetic socket that can be used with endoskeletal components;
Sufficient walking abilities to safely complete study activities.
Disqualifiers
Major contralateral limb amputation LLL on the contralateral limb;
Currently receiving physical therapy related to gait training or prosthesis use.
Trial design
Parallel
Treatments tested in this trial
Prosthetic foot
Other interventionThe most- and least-preferred prosthetic foot
Physical therapy
Other interventionPersonalized physical therapy
Treatment groups
Trial outcomes
Primary outcomes
Trinity Amputation and Prosthesis Experience Scales - Satisfaction
Patient-reported outcome measure that assesses functional satisfaction with the prosthesis. The maximum value is 15 and the minimum value is 5, with higher better scores meaning a better outcome. This sum score (max 15) is used for reporting and analysis.
Prosthetic Limb Users' Survey of Mobility
Patient-reported outcome measure that measures perceived mobility with a prosthesis. The maximum value is 60 and the minimum value is 12, with higher better scores meaning a better outcome. Scores are converted to t-scores for reporting and analysis.
Activities-specific Balance Confidence Scale
Patient-reported outcome measure that measures perceived balance confidence. The maximum value is 60 and the minimum value is 0, with higher better scores meaning a better outcome. Scores are converted to an average through dividing the sum by number of tasks (15) for reporting and analysis.
Timed up and go
Performance-based outcome measure that measures walking ability and dynamics balance. The time taken to complete the task is recorded as the score and less time means a better outcome.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: