Sonomyographic Upper Limb Prosthetics: A New Paradigm

NCT05376332 | Enrolling By Invitation FDA Device

• 2 other identifiers: 1492070-21U01EB027601
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (2)

• Fitt's Law Throughput

  The investigators will use throughput as the primary outcome measure for the Fitt's Law task. Throughput is defined as the ratio of index of difficulty to the movement time required for successful completion.

  at one week

• Southampton Hand Assessment Procedure (SHAP)

  The Southampton Hand Assessment Procedure (SHAP) will be the primary clinical outcome measure. The SHAP is a time-based test of a standardized protocol of 26 timed activities of daily living (ADL) tasks. The SHAP has a set of common objects representative of everyday items for the user to pick up. The results of the SHAP is a score which directly compares the abilities of the subject with those of intact able-bodied individuals as well as more refined scores for six prehensile patterns. A SHAP score of 100 is what an intact person is expected to achieve. Lower scores indicate worse function. This test has been validated for normative data.

  at two weeks

Secondary Outcomes (6)

• Fitt's Law Path Efficiency

  at one week

• Fitt's Law Completion Rate

  at one week

• Clothespin Relocation Test (CRT)

  at two weeks

• Gaze and Movement Assessment (GaMA)

  at two weeks

• Satisfaction with Prosthesis section of the Trinity Amputation and Prosthesis Scales - Revised (TAPES-R)

  Baseline

Study Arms (2)

Sonomyographic control

EXPERIMENTAL

Sonomyographic control involves the use of ultrasound signals from muscle deformation to control a prosthetic hand.

Device: Sonomyographic Prosthesis

Myoelectric control

ACTIVE COMPARATOR

Myoelectric control involves the use of surface electromyography signals from muscle activation to control a prosthetic hand.

Device: Myoelectric direct control prosthesis; Device: Myoelectric pattern recognition prosthesis

Interventions

Myoelectric direct control prosthesis DEVICE

The direct control system will include a custom-fitted test socket incorporating dual-site electrodes and controlling a TASKA prosthetic hand. All socket fittings will be performed by a board-certified prosthetist as part of this study.

Myoelectric control

Myoelectric pattern recognition prosthesis DEVICE

The pattern recognition system will include the subject's clinically-prescribed socket and commercially-available pattern recognition technology (IBT Sense). The pattern recognition system will not be fitted as part of this study, as subjects will already be trained users prior to enrolling in the study.

Myoelectric control

Sonomyographic Prosthesis DEVICE

The sonomyographic system will include a custom-fitted test socket incorporating ultrasound transducers and controlling a TASKA prosthetic hand. All socket fittings will be performed by a board-certified prosthetist as part of this study.

Sonomyographic control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transradial unilateral amputation
• Fluent in English
• For active comparator intervention 1 (myoelectric direct control prosthesis): Naïve to use of myoelectric prosthesis (i.e., uses body-powered prosthesis or has not used a myoelectric prosthesis for at least 3 years)
• For active comparator intervention 2 (myoelectric pattern recognition control prosthesis): Currently uses a commercially-available pattern recognition system (IBT Sense) with a terminal device having at least two degrees of freedom

You may not qualify if:

• Significant cognitive deficits as determined upon clinical evaluation
• Significant neurological deficits as determined upon clinical evaluation
• Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
• Uncontrolled pain or phantom pain impacting full participation in the study as determined upon OT evaluation
• Serious uncontrolled medical problems as judged by the project therapist

Sponsors & Collaborators

• George Mason University: lead
• Infinite Biomedical Technologies: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Peterson Health Sciences Hall

Fairfax, Virginia, 22030, United States

Location

Study Officials

• Siddhartha Sikdar, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover model: Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 17, 2022
• Study Start: November 2, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)