Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

NCT ID: NCT05695911

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2027-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Limb Load Biofeedback Training Intervention

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.

Group Type: EXPERIMENTAL

Limb Load Biofeedback Training Intervention

Intervention Type: BEHAVIORAL

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.

Attention Control Intervention

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.

Group Type: PLACEBO_COMPARATOR

Attention Control

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cory Christiansen, PT PHD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

CU Physical Therapy

Aurora, Colorado, United States

Countries

United States

Other Identifiers

CDMRPOP220013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-2116

Identifier Type: -

Identifier Source: org_study_id