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Prosthetics

Sonomyography-Controlled Prosthetics for Amputees

N/A

Waitlist Available

Led By Siddhartha Sikdar, PhD

Research Sponsored by George Mason University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Transradial unilateral amputation

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at one week

Awards & highlights

Study Summary

This trial is testing whether a new control system for upper extremity prosthetics, which uses imaging to sense residual muscle activity, is more effective than the current system which uses electromyography.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

As this trial involves non-invasive technology rather than drugs, traditional side effects are not applicable. However, participants may experience discomfort from the device fit or challenges adapting to the new control systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one arm amputated above the wrist.

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I currently use a pattern recognition prosthesis with at least two movement directions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fitt's Law Throughput

Southampton Hand Assessment Procedure (SHAP)

Secondary outcome measures

Clothespin Relocation Test (CRT)

Fitt's Law Completion Rate

Fitt's Law Path Efficiency

+3 more

Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

George Mason UniversityLead Sponsor

58 Previous Clinical Trials

48,778 Total Patients Enrolled

Infinite Biomedical TechnologiesIndustry Sponsor

4 Previous Clinical Trials

136 Total Patients Enrolled

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

89 Previous Clinical Trials

19,768 Total Patients Enrolled

1 Trials studying Prosthesis User

6 Patients Enrolled for Prosthesis User

Media Library

Sonomyographic Prosthesis (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05376332 — N/A

Prosthesis User Research Study Groups: Sonomyographic control, Myoelectric control

Prosthesis User Clinical Trial 2023: Sonomyographic Prosthesis Highlights & Side Effects. Trial Name: NCT05376332 — N/A

Sonomyographic Prosthesis (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05376332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being considered for this experiment?

"This clinical trial is welcoming volunteers aged 18 or above but under the age of 65."

Answered by AI

Are there still spots available for enrolment in this research project?

"Per the details on clinicaltrials.gov, this trial is not actively recruiting at present; it was first posted February 1st of 2023 and its last update was May 11th 2022. Notwithstanding, there are currently 70 other trials that require participants immediately."

Answered by AI

Could I qualify for participation in this research endeavor?

"To be eligible for consideration in this trial, potential participants must have suffered a limb amputation and fit into the age range of 18-65. Currently, 16 patients are being recruited."

Answered by AI

What objectives is this research endeavor attempting to fulfill?

"The purpose of this trial, spanning two weeks, is to measure Fitt's Law Throughput. In addition, the Trinity Amputation and Prosthesis Scales - Revised (TAPES-R), Gaze and Movement Assessment (GaMA) Protocol, and Orthotics and Prosthetics User Survey Upper Extremity Functional Status (OPUS-UEFS) will be evaluated; TAPES-R assesses psychosocial adjustment, activity restriction, aesthetic satisfaction with prosthesis among other factors over a score range of 1 to 30; GaMA utilises motion capture and eye tracking technology for object interaction tasks that yield quantitative"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sonomyographic Upper Limb Prosthetics: A New Paradigm

2023. "Sonomyographic Upper Limb Prosthetics: A New Paradigm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05376332.