Status:
UNKNOWN
Sonomyographic Upper Limb Prosthetics: A New Paradigm
Lead Sponsor:
George Mason University
Collaborating Sponsors:
Infinite Biomedical Technologies
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Amputation
Prosthesis User
Eligibility:
All Genders
18-65 years
Phase:
NA
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 eventuall...
Detailed Description
Specific Aim 1: Compare between sonomyography and myoelectric direct control The investigators would like to test the null hypothesis that there is no difference in performance on virtual environment ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05376332
Start Date
February 1 2023
End Date
January 31 2025
Last Update
May 17 2022
Active Locations (1)
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1
Peterson Health Sciences Hall
Fairfax, Virginia, United States, 22030