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

NCT06844305 | Not Yet Recruiting

• 2 other identifiers: OP230014HT9425-24-1-0319
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation of Lower Limb

Keywords

amputation; prosthesis; prescription; physical therapy; personalized

Outcome Measures

Primary Outcomes (6)

• 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.

  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

• 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.

  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

• 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.

  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

• 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.

  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

• Four square step test

  Performance-based outcome measure that measures dynamics balance. The time taken to complete the task is recorded as the score and less time means a better outcome.

  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

• Amputee Mobility Predictor

  Performance-based outcome measure that measures gait and balance. Each task is scored on an ordinal scale, and the maximum value is 47 and the minimum value is 0, with higher better scores meaning a better outcome.

  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

Study Arms (2)

Prosthesis Condition

OTHER

Participants experience walking with three prosthesis condition and select their most and least preferred.

Other: Prosthetic foot

Physical Therapy

ACTIVE COMPARATOR

Participants receive either the standard-of-care intervention (control) or an eight-week personalized physical therapy intervention.

Other: Physical therapy

Interventions

Prosthetic foot OTHER

The most- and least-preferred prosthetic foot

Prosthesis Condition

Physical therapy OTHER

Personalized physical therapy

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Major contralateral limb amputation LLL on the contralateral limb;
• Currently receiving physical therapy related to gait training or prosthesis use.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Prosthetics-Orthotics Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Matthew J Major, PhD

CONTACT

312-503-5731; matthew-major@northwestern.edu

Rebecca L Stine, MS

CONTACT

312-503-5726; rstine@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 25, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)