Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Abstract
Major limb amputations are among the most debilitating injuries that affect both active-duty Service Members and Veterans. Nearly 7.4% of all major extremity injuries suffered by U.S. military personnel during active duty end with major limb amputation. Unfortunately, nearly 85% of all military personnel who suffer limb loss will not return to active duty, resulting in a significant loss of highly trained Warfighters. Furthermore, limb loss also has a profoundly negative effect on individual health in the Veteran population, primarily due to limited prosthesis use and physical activity. The low retention rates and negative impact on health in both populations are primarily caused by socket-related complications (e.g., poor fit, chronic blisters, volume fluctuations, etc.) and chronic joint injuries (e.g., low back pain, osteoarthritis). Osseointegrated (OI) prostheses are a novel alternative to socket prostheses, as OI prostheses directly mount the prosthetic limb to the amputated limb through a medical implant into the bone. OI prosthesis implantation allows the amputated limb bone to be loaded more directly than a socket prosthesis. Within the University of Colorado Limb Restoration Clinic, this new prosthesis has been met with astoundingly positive improvements in mobility and quality of life. However, our pilot data also demonstrate asymmetrical joint loading 1 year after OI implantation, likely caused by persistently altered movement behaviors. This loading asymmetry is important because loads applied to the implant during daily activities are vital to long-term outcomes. Too high of loads, either short-term or over a prolonged period, may result in bone fracture, while too low of loads may not promote proper healing between the bone and implant. As such, the primary focus in rehabilitation is driven by tight restrictions on progressive loading during physical rehabilitation to stimulate osseointegration between the bone and implant to ready the limb for activities of daily living. However, due to its novelty, current standard of care rehabilitation protocols immediately following OI prosthesis implantation are based on limited evidence and lack validation. Furthermore, there is standard for intervention to promote and maintain healthy prosthesis and limb loading after acute rehabilitation. Therefore, our overarching objective is to test the feasibility of the first-of-its-kind limb-load biofeedback training intervention in patients with OI prostheses. We propose a single-site, randomized, controlled Phase I clinical trial that will be integrated within the standard of care rehabilitation following OI prosthesis implantation. The intervention will be integrated into current standard of care in a manner that optimizes intervention delivery, provides direct user feedback with wearable technology, is safe, and is patient centered. This intervention will target improved between-limb load symmetry in patients with OI prostheses by using established behavior change methods and motor learning principles with instrumented insoles for limb-load biofeedback training. To accomplish this, this proposal will implement three specific aims: Aim 1: Determine if the limb-load biofeedback intervention is feasible to implement and acceptable in its form for people with transfemoral OI prostheses. We will test feasibility in terms of patient participant retention, the ability to deliver the intervention as prescribed (intervention fidelity), intervention acceptability rating by the patient participants, and the relative number of adverse events between the control and intervention groups. Aim 2: Determine if this intervention effects limb loading. Between-group changes over a 64-week period (pre-OI to 52 weeks post-OI surgery) will be assessed for between-limb cumulative loading symmetry. We will also assess group change for between-limb joint biomechanics symmetry and clinical outcome measures (free-living daily step count,
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310047
Entities
People
- Cory Christiansen
Organizations
- United States Army
- University of Colorado Denver