Safety and Feasibility of ExoNET

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient population.

Detailed Description
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The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology. The primary objective of this study is to evaluate the safety, feasibility and efficacy using the ExoNET. Specifically, investigators want to see if the ExoNET tuned to gravity support will lead to a reduction in bicep muscle activity and an increase in range of motion. To accomplish this aim, we plan to have participants perform reaching, arm elevation and flexion task exercises wearing the ExoNET. To achieve these goals, we will use a wearable activity tracker (MiGo), to detect the number of activities performed, a wearable surface EMG system (Delsys) on the bicep muscles and a markerless system called the Kinect (version 2) to collect distribution of motion. Investigators hypothesize that individuals with post-stroke arm movement deficits treated with ExoNET gravity compensation will improve their ARAT measures more than controls receiving a sham treatment. Secondarily, treated subjects will improve in other clinical metrics and will make more movements than controls.

Official Title
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Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke

Conditions
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Stroke, Cerebral Vascular Accident

Intervention / Treatment
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* Device: ExoNet Tuned to Gravity Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or hemorrhagic stroke (8 months post stroke) Available medical records and radiographic information about lesion locations Hemiparesis Some degree of both shoulder and elbow movement capability A moderate impairment (Fugl-Meyer score between 15-50) Exclusion Criteria: Individuals under the age of 18 Bilateral paresis Shoulder pain and/or articular rigidity on the upper limb joint Spasticity (Modified Ashworth Scale of 2) Botox injection to the affected upper extremity within the previous 4 months Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group: Gravity Compensation<br>The participants will be wearing the ExoNet device tuned to gravity support. | Device: ExoNet Tuned to Gravity Support<br>* This study's primary goal is to test the safety, feasibility, and efficacy of the ExoNET device developed in the Robotics Lab at the Shirley Ryan AbilityLab. We want to observe if individuals using the ExoNET tuned to gravity support will notice a reduction in bicep muscle activity, leading to an improvement in functional outcome measures in stroke patients.<br>|
| Sham Comparator: Control Group: No Gravity Compensation<br>The participants will be wearing the ExoNet device, but it will not be tuned to gravity support. | Device: ExoNet Tuned to Gravity Support<br>* This study's primary goal is to test the safety, feasibility, and efficacy of the ExoNET device developed in the Robotics Lab at the Shirley Ryan AbilityLab. We want to observe if individuals using the ExoNET tuned to gravity support will notice a reduction in bicep muscle activity, leading to an improvement in functional outcome measures in stroke patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system | Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer | observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system | Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations) | 
| Wolf Motor Function Test | Quantitative measure of change of upper extremity motor ability | Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations) | 
| Box and Blocks | Measures change in unilateral gross motor dexterity | Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity, Rehabilitation, Stroke