Improving control of bone-anchored above-elbow prostheses

Optimizing Transhumeral Osseointegration Prosthesis Control

This project will test if muscle-signal training helps adults with above-elbow (transhumeral) amputations control bone-anchored myoelectric prostheses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 2 sites (Edmonton, Alberta and 1 other locations)
• Trial ID: NCT06853938 on ClinicalTrials.gov

What this trial studies

The study enrolls adults with transhumeral amputations who are scheduled for osseointegration through the Alberta Limb Osseointegration Program. Participants will receive myoelectric muscle-signal training and use a myoelectric prosthesis integrated with a bone-anchored implant to measure control and functional performance. Researchers will collect data on signal reliability, task-based function, and follow-up outcomes before and after prosthesis fitting. The work takes place at the University of Alberta and Glenrose Rehabilitation Hospital using standardized functional assessments.

Who should consider this trial

Good fit: Adults 18–65 with a transhumeral amputation who are scheduled for osseointegration, have pain-free shoulder range of motion, and demonstrate usable muscle signals for myoelectric control are the ideal candidates.

Not a fit: Patients with insufficient muscle signals, significant shoulder pathology that limits training or testing, inability to comply with follow-up, or who are not undergoing osseointegration are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could give participants more reliable prosthesis control, making daily tasks easier and reducing problems caused by socket fit.

How similar studies have performed: Prior work shows osseointegration can improve prosthesis comfort and myoelectric control can work for some amputees, but combining osseointegration with targeted myoelectric training for transhumeral users is still an emerging approach.

Eligibility criteria

Inclusion Criteria:

Individuals with transhumeral amputation who:

1. are between 18 and 65 years old,
2. have been scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program.
3. demonstrate adequate pain-free shoulder range of motion to perform the required tasks and have potential muscle signals for myoelectric control to be able to undertake the muscle signal training
4. willing to undergo all of the study procedures and follow-up.

Exclusion Criteria:

Individuals who:

1. are unable to comply with treatment or follow-up processes,
2. are unable to understand English sufficiently to provide full informed consent.
3. have shoulder pathology on the side of the amputation (arthritis, adhesive capsulitis, chronic rotator cuff, or musculoskeletal dysfunction) that would negatively affect the ability to perform the training and functional assessments,
4. have insufficient muscle signals to operate a myoelectric prosthesis

Where this trial is running

Edmonton, Alberta and 1 other locations

• Glenrose Rehabilitation Hospital — Edmonton, Alberta, Canada (Recruiting)
• University of Alberta — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Jacqueline S Hebert, MD, FRCPC

Conditions Transhumeral Amputation