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

A Personalized, Patient-Centered Prosthetic Foot Prescription and Rehabilitation Strategy to Maximize Mobility and Satisfaction in Veterans With Lower Limb Loss

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amputation of Lower Limb
• Intervention / Treatment: Other: Prosthetic foot; Other: Physical therapy

Detailed Description

Aim 1: Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction. Baseline mobility and satisfaction of 50 Veterans with unilateral transtibial amputation (UTTA) will initially be evaluated with their currently prescribed prosthesis. Participants will then walk with the Variable-Stiffness Prosthetic Ankle (VSPA) Foot across real-world mobility scenarios inside and outside the laboratory. During this protocol, participants will experience three different VSPA Foot conditions that emulate different commercial feet to determine each participant's most- and least-preferred foot (with further opportunity for fine-tuning to determine the optimal stiffness category of their most 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. Aim 2: Assess the effect of a targeted physical therapy (PT) intervention following preference-based foot selection on mobility, balance, and satisfaction. After a two-week, community-based accommodation period with their most preferred commercial foot, participants' satisfaction, perceived and functional mobility, and balance will be measured. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized PT intervention that targets and addresses impairments in mobility and balance and patient-specific functional goals (intervention group). Following eight weeks of either standard-of-care or PT intervention, participants' satisfaction, mobility, and balance will again be measured and compared between groups (intervention vs. control) and across time periods (pre- vs. post-accommodation measurements).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew J Major, PhD; Phone Number: 312-503-5731; Email: matthew-major@northwestern.edu
• Study Contact Backup: Name: Rebecca L Stine, MS; Phone Number: 312-503-5726; Email: rstine@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Prosthetics-Orthotics Center
      • Contact: Matthew J Major, PhD; Phone Number: 312-503-5731; Email: matthew-major@northwestern.edu
      • Contact: Rebecca L Stine, MS; Phone Number: 312-503-5726; Email: rstine@northwestern.edu
      • Principal Investigator: Matthew J Major, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prosthesis Condition; Participants experience walking with three prosthesis condition and select their most and least preferred.	Other: Prosthetic foot; The most- and least-preferred prosthetic foot
Active Comparator: Physical Therapy; Participants receive either the standard-of-care intervention (control) or an eight-week personalized physical therapy intervention.	Other: Physical therapy; Personalized physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: prosthesis; physical therapy; amputation; prescription; personalized
• Additional Relevant MeSH Terms: Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: OP230014; HT9425-24-1-0319 (Other Grant/Funding Number: US Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No