Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training (TOPLOAD)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Transfemoral Amputation; Amputation; Osseointegration

Treatments: Behavioral: Limb Load Biofeedback Training Intervention; Other: Attention Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05695911

CDMRPOP220013 (Other Grant/Funding Number)

22-2116

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Limb Load Biofeedback Training Intervention

Experimental group

Description:

The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb loading symmetry. Participants randomized to the EXP group will receive 12 biofeedback training sessions (1 in-person, 11 telehealth) tapered over 40 weeks.

Treatment:

Behavioral: Limb Load Biofeedback Training Intervention

Attention Control Intervention

Placebo Comparator group

Description:

The CTL group intervention will include the same standard of care rehabilitation sessions as the EXP group and receive the same computer tablets for telehealth sessions as the EXP group. The CTL group will also have attention control educational sessions at the same frequency, timing, and duration as the EXP group limb-load biofeedback sessions (12 total sessions) with the first session being an in-person session at the Week 24. There will be no biofeedback training intervention in the CTL group. As such, there will be no behavioral intervention or wearable sensors provided to the CTL group. The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group.

Treatment:

Other: Attention Control