Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Running, not enrolling · Not applicable

Conditions studied: Amputation, Transfemoral Amputation, Osseointegration

In brief

This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

Key facts

Study ID

NCT05695911

Run by

University of Colorado, Denver

People needed

25

Starts

2023-01-30

Expected to finish

2027-01-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
• ≥ 18 years old
• History of severe socket-related skin or residual limb problems
• Schedule for OI prosthesis implantation surgery

You may not qualify if…

• Vascular amputation etiology
• Substance abuse
• Unstable heart condition
• Acute systemic infection
• Cognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)
• Active cancer treatment

Where it is running

• CU Physical Therapy — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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