Improving Myoelectric Prosthetic and Orthotic Limb Control
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 6, 2026
April 1, 2026
10.4 years
August 15, 2022
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Box and Blocks Test (BBT)
The Box and Blocks test is performed using the orthotic device under each condition. The individual puts on the device for a maximum of two hours. During that time wearing the device, they will use two different algorithms for controlling the device to complete the Box and Blocks Test.
while using the device (up to 2 hours)
Study Arms (2)
Clinically Available Control Algorithm (MyoPro)
ACTIVE COMPARATORBinary control of the orthosis is based on a clinically available control algorithm. This condition serves as a control. Participants will use a commercially available device, the MyoPro.
High-Density EMG Control Algorithm
EXPERIMENTALControl of the orthosis is based on residual muscle activity mapped to intended movement using advanced predicted algorithms. This condition is a novel algorithm and serves as the experimental condition.
Interventions
Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.
Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.
Eligibility Criteria
You may qualify if:
- First-ever ischemic or hemorrhagic stroke
- Chronic Stroke (at least 6 months since onset)
- Chronic hemiparesis
- Functional range of motion for contralateral arm
You may not qualify if:
- Individuals who are currently Incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132-2101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 15, 2022
First Posted
August 19, 2022
Study Start
March 1, 2017
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04