16 Participants Needed

Sonomyography-Controlled Prosthetics for Amputees

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: George Mason University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

SS

Siddhartha Sikdar, PhD

Principal Investigator

George Mason University

Eligibility Criteria

This trial is for individuals with a transradial unilateral amputation who speak English. Participants must either be new to myoelectric prostheses or currently use a specific commercial pattern recognition prosthesis. People with significant cognitive, neurological, or physical deficits, uncontrolled pain, or serious medical problems cannot participate.

Inclusion Criteria

Fluent in English
I have not used a myoelectric prosthesis for at least 3 years.
I have had one arm amputated above the wrist.
See 1 more

Exclusion Criteria

My health issues are under control, as confirmed by my doctor.
My pain is not well-managed and affects my daily activities.
My limb loss affects my ability to fully participate in the study.
See 2 more

Treatment Details

Interventions

  • Myoelectric direct control prosthesis
  • Myoelectric pattern recognition prosthesis
  • Sonomyographic Prosthesis
Trial OverviewThe study tests a new sonomyographic prosthetic control system against two types of myoelectric prostheses: direct control and pattern recognition. The goal is to improve functionality in upper limb prosthetics by using ultrasound imaging to sense muscle activity for more intuitive control.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Sonomyographic controlExperimental Treatment1 Intervention
Sonomyographic control involves the use of ultrasound signals from muscle deformation to control a prosthetic hand.
Group II: Myoelectric controlActive Control2 Interventions
Myoelectric control involves the use of surface electromyography signals from muscle activation to control a prosthetic hand.

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Who Is Running the Clinical Trial?

George Mason University

Lead Sponsor

Trials
60
Recruited
50,200+

Infinite Biomedical Technologies

Industry Sponsor

Trials
7
Recruited
160+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+