Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training — TOPLOAD  

Amputation Clinical Trial

Official title: Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial. ;

Related Conditions & MeSH terms

• Amputation
• Transfemoral Amputation

• NCT number: NCT05695911
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Cory Christiansen, PT PHD
• Phone: 303 724 9101
• Email: CORY.CHRISTIANSEN@CUANSCHUTZ.EDU
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Completion date: January 31, 2026