Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Description

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).

Conditions

Amputation, Transfemoral Amputation, Osseointegration

Study Overview

Study Details

Study overview

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).

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Aurora

CU Physical Therapy, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Cory Christiansen, PT PHD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2026-01-31