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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05509101
Other study ID # IRB_00098851
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date August 31, 2025

Study information

Verified date September 2023
Source University of Utah
Contact Heidi Hansen, BS
Phone 801.585.2373
Email heidi.hansen@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
commercially available control algorithm
Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.
experimental control algorithm
Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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