Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

NCT05695911 | Active Not Recruiting

• 2 other identifiers: 22-2116CDMRPOP220013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Amputation; Transfemoral Amputation; Osseointegration

Keywords

amputation; osseointegration; rehabilitation; biofeedback

Outcome Measures

Primary Outcomes (5)

• Intervention Feasibility

  Intervention feasibility is measured by retention rate, the percentage of people that complete the study. A score can range between 0 and 100 percent with 100 percent meaning all randomized participants completed the study.

  Week 64

• Intervention Participant Acceptability

  Acceptability of an intervention is the perception among stakeholders (e.g., patients and clinicians) that the intervention is agreeable or satisfactory. To measure participant acceptability, the investigators will use the Acceptability of Intervention Measure, a 30 four-item survey of stakeholder perception of intervention acceptability that asks participants to provide their approval as well as intervention appeal, likability, and agreeability. The scores range from 1 (completely disagree) to 5 (completely agree). The investigators expect the Acceptability of Intervention Measure score (average of the four items on a 1-5 scale) for the EXP group to be at least 4 (agree).

  Week 64

• Intervention Fidelity

  This will be evaluated based on whether EXP group interventionists deliver the intervention as planned and quantified in three ways: adherence, delivery quality, and patient engagement. The investigators will use the overall results of these three fidelity components to create a total score. Fidelity scores are reported as a percentage from 0 to 100 with 100 representing full fidelity. The investigators will consider \>85% fidelity (average across all three components) to intervention delivery as a positive result.

  Week 64

• Change in Cumulative Loading

  Free-living physical activity will be objectively monitored over a 10-day period using an activPAL micro accelerometer-based sensor (PAL Technologies, Glasgow, UK). Interlimb cumulative loading will be measured as a product of daily step count and ground reaction force impulse. Cumulative loading = (Daily Steps/2)\*ground reaction force impulse.

  Week 5, Week 64

• Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand

  Bilateral hip movement patterns (joint angles), muscle forces, and joint reaction forces will be calculated during functional tasks of increasing biomechanical demand (walking, sitting, stepping, turning) using a combination of motion capture and subject-specific musculoskeletal models. Whole-body motion capture will be collected from 70 reflective markers (Fs=120 Hz) (Vicon, Centennial, CO) with ground reaction forces simultaneously collected from six embedded force platforms (Fs=2,160 Hz) (Bertec, Columbus, OH). A subject-specific musculoskeletal model will be created using OpenSim software.

  Week 5, Week 64

Secondary Outcomes (7)

• Change in World Health Organization-Disability Assessment Schedule 2.0

  Week 5, Week 24 and Week 64

• Change in Activities Specific Balance Confidence Scale

  Week 5, Week 24 and Week 64

• Change in Prosthetic Limb Users Survey of Mobility

  Week 5, Week 24 and Week 64

• Change in Patient Specific Function Scale

  Week 5, Week 24 and Week 64

• Change in Self Selected Gait Speed

  Week 5 and Week 64

Study Arms (2)

Limb Load Biofeedback Training Intervention

EXPERIMENTAL

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.

Behavioral: Limb Load Biofeedback Training Intervention

Attention Control Intervention

PLACEBO COMPARATOR

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.

Other: Attention Control

Interventions

Limb Load Biofeedback Training Intervention 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.

Limb Load Biofeedback Training Intervention

Attention Control 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).

Attention Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vascular amputation etiology
• Substance abuse
• Unstable heart condition
• Acute systemic infection
• Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24)
• Active cancer treatment

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (1)

CU Physical Therapy

Aurora, Colorado, 80045, United States

Location

Study Officials

• Cory Christiansen, PT PHD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized by ratio of 1:2 in the CTL to EXP group.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 25, 2023
• Study Start: January 30, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The investigators will publish the trial results within one year of testing the final participant.
• Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with CDMRP Policy on Sharing Data and Research Resources.

Locations

US (1)