Safety and Feasibility of ExoNET

Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Cerebral Vascular Accident
• Intervention / Treatment: Device: ExoNet Tuned to Gravity Support

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ischemic or hemorrhagic stroke (8 months post stroke)
2. Available medical records and radiographic information about lesion locations
3. Hemiparesis
4. Some degree of both shoulder and elbow movement capability
5. A "moderate" impairment (Fugl-Meyer score between 15-50)

Exclusion Criteria:

1. Individuals under the age of 18
2. Bilateral paresis
3. Shoulder pain and/or articular rigidity on the upper limb joint
4. Spasticity (Modified Ashworth Scale of 2)
5. Botox injection to the affected upper extremity within the previous 4 months
6. Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography using Delsys	Delsys sensors will be used to measure change in biceps activity	Treatment phases (week 2 and week 3)
Kinect	markerless system to collect changes of distribution of motion	Treatment phases (week 2 and week 3)

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 12, 2023
• Study Completion (Estimated): July 12, 2026

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper Extremity
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: STU00216062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No