← Back to all trials
Recruiting
NCT05695911
Transfemoral Osseointergrated Prosthesis Limb Load Symmetry Training
Conditions: Amputation, Transfemoral Amputation, Osseointegration
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 25
Sponsor: University of Colorado, Denver
Location: United States
Summary
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).
Eligibility Criteria
Inclusion Criteria:Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes≥ 18 years oldHistory of severe socket-related skin or residual limb problemsSchedule for OI prosthesis implantation surgeryExclusion Criteria:Vascular amputation etiologySubstance abuseUnstable heart conditionAcute systemic infectionCognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)Active cancer treatment
Source: ClinicalTrials.gov (NCT05695911). StuddyBuddy aggregates publicly available trial information.