Back to resultsImproving Myoelectric Prosthetic and Orthotic Limb Control
Primary Purpose
Hemiparesis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
commercially available control algorithm
experimental control algorithm
Sponsored by
About this trial
This is an interventional other trial for Hemiparesis
Eligibility Criteria
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
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clinically Available Control Algorithm (MyoPro)
High-Density EMG Control Algorithm
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05509101
Brief Title
Improving Myoelectric Prosthetic and Orthotic Limb Control
Official Title
Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinically Available Control Algorithm (MyoPro)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-Density EMG Control Algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
commercially available control algorithm
Intervention Description
Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.
Intervention Type
Other
Intervention Name(s)
experimental control algorithm
Intervention Description
Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.
Primary Outcome Measure Information:
Title
Box and Blocks Test (BBT)
Description
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.
Time Frame
while using the device (up to 2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Hansen, BS
Phone
801.585.2373
Email
heidi.hansen@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Wilson, BS
Phone
801.581.8911
Email
jacob.wilson@hsc.utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Hansen
Phone
801-585-2373
Email
heidi.hansen@hsc.utah.edu
12. IPD Sharing Statement
Learn more about this trial
Improving Myoelectric Prosthetic and Orthotic Limb Control
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