NCT05695911

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Amputation
• Transfemoral Amputation
• Osseointegration

Interventions

Type	Name	Description
BEHAVIORAL	Limb Load Biofeedback Training Intervention	Loadsol data will be used to inform the EXP telehealth sessions, as the interventionist guides the participant to self-monitor their movement, problem solve movement patterns that promote asymmetrical limb loading, and create weekly action plans for improving limb load symmetry. Weekly goals will be made in the context of functional task progression over the 40-week intervention.
OTHER	Attention Control	The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group. The CTL group sessions will include a review of the standard of care home-exercises, a summary of healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use, home safety).

Timeline

• Start date: 2023-01-30
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2023-01-25
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States