- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509101
Improving Myoelectric Prosthetic and Orthotic Limb Control
April 29, 2026 updated by: Jacob George, University of Utah
Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study looks to improve control of myoelectrically-controlled advanced powered orthoses (orthoses that use the body's muscle signals to drive movements of a robotic exoskeleton) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG) electrodes.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heidi Hansen, BS
- Phone Number: 801.585.2373
- Email: heidi.hansen@hsc.utah.edu
Study Contact Backup
- Name: Jacob Wilson, BS
- Phone Number: 801.581.8911
- Email: jacob.wilson@hsc.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132-2101
- Recruiting
- University of Utah
-
Contact:
- Heidi Hansen
- Phone Number: 801.585.2373
- Email: heidi.hansen@hsc.utah.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- First-ever ischemic or hemorrhagic stroke
- Chronic Stroke (at least 6 months since onset)
- Chronic hemiparesis
- Functional range of motion for contralateral arm
Exclusion Criteria:
- Individuals who are currently Incarcerated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Clinically Available Control Algorithm (MyoPro)
Binary 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.
|
Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.
|
|
Experimental: High-Density EMG Control Algorithm
Control 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.
|
Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Blocks Test (BBT)
Time Frame: while using the device (up to 2 hours)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
August 15, 2022
First Submitted That Met QC Criteria
August 17, 2022
First Posted (Actual)
August 19, 2022
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00098851
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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