Shirley Ryan AbilityLab
Chicago, Illinois, 60610, United States
NCT Number: NCT05180812
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60610, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
Measures change in unilateral gross motor dexterity
Time frame: Treatment phases (week 2 and week 3)
Delsys sensors will be used to measure change in biceps activity
Time frame: Treatment phases (week 2 and week 3)
markerless system to collect changes of distribution of motion
Shirley Ryan AbilityLab
Other
Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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