Personalized Prosthetic Foot Prescription and Rehabilitation for Veterans With Lower Limb Loss

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Prosthetic foot

    Other intervention

    The most- and least-preferred prosthetic foot

  • Physical therapy

    Other intervention

    Personalized physical therapy

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Prosthesis ConditionOther 1 intervention
Group B: Physical TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
2

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.

Time frame
From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
3

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.

Time frame
From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
4

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.

Time frame
From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: