Training program for improving limb-load symmetry in transfemoral amputees with osseointegrated prostheses
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
This study is testing a 40-week training program to see if it can help people with transfemoral osseointegrated prostheses walk more evenly and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05695911 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to assess the feasibility and efficacy of a 40-week limb-load biofeedback training intervention for individuals with transfemoral osseointegrated prostheses. Participants will be divided into a training group receiving biofeedback and a control group receiving standard care. Outcomes will be evaluated at multiple time points, including pre-surgery, post-training, and one year after surgery, to identify functional movement priorities and improve rehabilitation strategies. The study seeks to provide empirical evidence to enhance post-operative rehabilitation guidelines for this population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral transfemoral amputation due to traumatic, congenital, or cancer-related causes who are scheduled for osseointegration surgery.
Not a fit: Patients with vascular amputation etiology, cognitive impairments, or those undergoing active cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve rehabilitation outcomes and quality of life for patients with transfemoral osseointegrated prostheses.
How similar studies have performed: While this approach is novel, previous studies have indicated the potential benefits of biofeedback in rehabilitation, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * Vascular amputation etiology * Substance abuse * Unstable heart condition * Acute systemic infection * Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24) * Active cancer treatment
Where this trial is running
Aurora, Colorado
- CU Physical Therapy — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Cory Christiansen, PT PHD — University of Colorado, Denver
- Study coordinator: Cory Christiansen, PT PHD
- Email: CORY.CHRISTIANSEN@CUANSCHUTZ.EDU
- Phone: 303 724 9101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.