Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06853938

Optimizing Transhumeral Osseointegration Prosthesis Control

Led by University of Alberta · Updated on 2025-11-18

5

Participants Needed

2

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Above-elbow prostheses are particularly challenging to use for several reasons. The socket must go all the way into the shoulder for stability. To hold the prosthesis onto the remaining arm, there needs to be a strap across the chest and shoulder. The prosthesis can be heavy, and the socket can slip or move around. This makes it hard to use muscle signals in the residual limb to control advanced prosthetic devices. People with limb loss are interested in advanced prostheses to use them reliably for day-to-day activities. Bone-anchored prostheses (BAPs) are a new approach. They are for people with upper limb loss who can't use socket prostheses. The surgery involves putting a titanium rod into the remaining bone, which, over time, joins with the bone. This implant extends through the skin. It enables the direct attachment of the prosthetic parts (like the elbow and hand). With BAPs, there is no need for a socket. Also, there is a well-known surgery called "Targeted muscle reinnervation" (TMR). It improves the number of arm muscle control signals. These signals are used to control myoelectric prostheses. However, after both these surgeries, there is a lack of research that shows how best to train the muscle signals to use an advanced myoelectric arm and little evidence on what factors actually improve in a person's day-to-day life when using such a prosthesis. This study aims to implement an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving OI and TMR for above-elbow amputation, and to evaluate the outcomes over time. The goal is to understand whether these advanced prostheses improve prosthesis use and function in daily life.

CONDITIONS

Official Title

Optimizing Transhumeral Osseointegration Prosthesis Control

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with transhumeral amputation between 18 and 65 years old
  • Scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program
  • Have adequate pain-free shoulder range of motion and sufficient muscle signals for myoelectric control
  • Willing to complete all study procedures and follow-up
Not Eligible

You will not qualify if you...

  • Unable to comply with treatment or follow-up requirements
  • Unable to understand English well enough to give informed consent
  • Have shoulder problems on the amputated side that affect training or functional assessments
  • Have insufficient muscle signals to operate a myoelectric prosthesis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada, T5G 0B7

Actively Recruiting

2

University of Alberta

Edmonton, Alberta, Canada, T6G2R3

Actively Recruiting

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Research Team

J

Jacqueline S Hebert, MD, FRCPC

CONTACT

M

Mayank Rehani, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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