Safety and Feasibility of ExoNET
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group: Gravity Compensation The participants will be wearing the ExoNet device tuned to gravity support. |
Device: ExoNet Tuned to Gravity Support
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.
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| Sham Comparator: Control Group: No Gravity Compensation The participants will be wearing the ExoNet device, but it will not be tuned to gravity support. |
Device: ExoNet Tuned to Gravity Support
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.
|
Outcome Measures
Primary Outcome Measures
- Action Research Arm Test [Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)]
observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
Secondary Outcome Measures
- Fugl-Meyer [Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)]
observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system
- Wolf Motor Function Test [Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)]
Quantitative measure of change of upper extremity motor ability
- Box and Blocks [Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)]
Measures change in unilateral gross motor dexterity
Other Outcome Measures
- Electromyography using Delsys [Treatment phases (week 2 and week 3)]
Delsys sensors will be used to measure change in biceps activity
- Kinect [Treatment phases (week 2 and week 3)]
markerless system to collect changes of distribution of motion
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ischemic or hemorrhagic stroke (8 months post stroke)
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Available medical records and radiographic information about lesion locations
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Hemiparesis
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Some degree of both shoulder and elbow movement capability
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A "moderate" impairment (Fugl-Meyer score between 15-50)
Exclusion Criteria:
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Individuals under the age of 18
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Bilateral paresis
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Shoulder pain and/or articular rigidity on the upper limb joint
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Spasticity (Modified Ashworth Scale of 2)
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Botox injection to the affected upper extremity within the previous 4 months
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Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shirley Ryan AbilityLab | Chicago | Illinois | United States | 60610 |
Sponsors and Collaborators
- Shirley Ryan AbilityLab
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5.
- Lannin NA, Cusick A, Hills C, Kinnear B, Vogel K, Matthews K, Bowring G. Upper limb motor training using a Saebo(™) orthosis is feasible for increasing task-specific practice in hospital after stroke. Aust Occup Ther J. 2016 Dec;63(6):364-372. doi: 10.1111/1440-1630.12330. Epub 2016 Sep 19.
- Reichenfelser, W., Gföhler, M., & Karner, J. (2012). Design concept for a mobile arm support. Gait & Posture, (36), S77.
- Ryali, P., Carella, T., McDermed, D., Perizes, V., Huang, F., & Patton, J. (2020). A Theoretical Framework for a Network of Elastic Elements Generating Arbitrary Torque Fields. In 2020 8th IEEE RAS/EMBS International Conference for Biomedical Robotics and Biomechatronics (BioRob) (pp. 286-291). IEEE.
- STU00216062