Safety and Feasibility of ExoNET

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.

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.

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.

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)

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)

Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

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

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.