MedTrace Logo

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

NCT05695911 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Cory Christiansen, PT PHD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695911 on ClinicalTrials.gov