NCT05376332

Sonomyographic Upper Limb Prosthetics: A New Paradigm

ENROLLING BY INVITATION NA Last updated 3 February 2026

What this trial tests

NA trial testing Sonomyographic Prosthesis in Amputation in 16 participants. Enrolling by invitation.

Timeline

2 November 2023

Primary endpoint
31 July 2026

31 July 2026

Quick facts

Lead sponsor	George Mason University
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	2 November 2023
Primary completion	31 July 2026
Estimated completion	31 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Sonomyographic Prosthesis
• Myoelectric direct control prosthesis
• Myoelectric pattern recognition prosthesis

Conditions studied

• Amputation — all drugs for Amputation →
• Prosthesis User — all drugs for Prosthesis User →

Sponsor

George Mason University

Who can join

Adults 18 to 65, any sex, with Amputation or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The vast majority of all trauma-related amputations in the United States involve the upper limbs. Approximately half of those individuals who receive a upper extremity myoelectric prosthesis eventually abandon use of the system, primarily because of their limited functionality. Thus, there continues to be a need for a significant improvement in prosthetic control strategies.

The objective of this bioengineering research program is to develop and clinically evaluate a prototype prosthetic control system that uses imaging to sense residual muscle activity, rather than electromyography. This novel approach can better distinguish between different functional compartments in the forearm muscles, and provide robust control signals that are proportional to muscle activity. This improved sensing strategy has the potential to significantly improve functionality of upper extremity prostheses, and provide dexterous intuitive control that is a significant improvement over current state of the art noninvasive control methods. This interdisciplinary project brings together investigators at George Mason University, commercial partners at Infinite Biomedical Technologies as well as clinicians at MedStar National Rehabilitation Hospital.

The investigators will optimize and implement algorithms for real-time classification and control with multiple degrees of freedom (DOF) using a miniaturized ultrasound system incorporated into a prosthetic socket. The investigators will then compare control performance between and sonomyography and myoelectric control (both direct control and pattern recognition) using a virtual environment as well as for performance of tasks related to activities of daily living. The investigators have two specific aims.

Specific Aim 1: Compare between sonomyography and myoelectric direct control Specific Aim 2: Compare between sonomyography and pattern recognition with velocity control The successful completion of this project will lead to the first in human evaluation of an integrated prototype that uses low-power portable imaging sensors and real-time image analysis to sense residual muscle activity for prosthetic control. In the long term, the investigators anticipate that the improvements in functionality and intuitiveness of control will increase acceptance by amputees.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.