Sonomyographic Upper Limb Prosthetics: A New Paradigm - Trial NCT05376332

Timeline & Enrollment

Primary Outcome

Fitt's Law Throughput,Southampton Hand Assessment Procedure (SHAP)

Summary

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.

ICD-10 Classifications