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

Conditions

• Amputation of Lower Limb

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prosthetic foot — OTHER
  The most- and least-preferred prosthetic foot
• Physical therapy — OTHER
  Personalized physical therapy

Study Details

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.

Key Dates

Start date

Dec 31, 2026

Status verified

Jun 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Prosthesis Condition
  Participants experience walking with three prosthesis condition and select their most and least preferred.
• Active Comparator: Physical Therapy
  Participants receive either the standard-of-care intervention (control) or an eight-week personalized physical therapy intervention.

Primary Outcome Measure

Trinity Amputation and Prosthesis Experience Scales - Satisfaction [ 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 ]

Central Contacts

• Matthew J Major, PhD
  312-503-5731
  [email protected]
• Rebecca L Stine, MS
  312-503-5726
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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