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

NCT ID: NCT06844305

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2029-05-31

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.

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).

Conditions

Amputation of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prosthesis Condition

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

Group Type: OTHER

Prosthetic foot

Intervention Type: OTHER

The most- and least-preferred prosthetic foot

Physical Therapy

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

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

Personalized physical therapy

Interventions

Prosthetic foot

The most- and least-preferred prosthetic foot

Intervention Type: OTHER

Physical therapy

Personalized physical therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Major

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University Prosthetics-Orthotics Center

Chicago, Illinois, United States

Countries

United States

Central Contacts

Matthew J Major, PhD

Role: CONTACT

matthew-major@northwestern.edu

312-503-5731

Rebecca L Stine, MS

Role: CONTACT

rstine@northwestern.edu

312-503-5726

Facility Contacts

Matthew J Major, PhD

Role: primary

matthew-major@northwestern.edu

312-503-5731

Rebecca L Stine, MS

Role: backup

rstine@northwestern.edu

312-503-5726

Other Identifiers

HT9425-24-1-0319

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OP230014

Identifier Type: -

Identifier Source: org_study_id