Improving Myoelectric Prosthetic and Orthotic Limb Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes

Conditions
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Hemiparesis

Intervention / Treatment
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* Other: commercially available control algorithm
* Other: experimental control algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinically Available Control Algorithm (MyoPro)<br>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. | Other: commercially available control algorithm<br>* Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.<br>|
| Experimental: High-Density EMG Control Algorithm<br>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. | Other: experimental control algorithm<br>* Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |