Safety and Feasibility of ExoNET

Not Applicable

Active, not recruiting

• Conditions: Cerebral Vascular Accident; Stroke
• Interventions: Device: ExoNet Tuned to Gravity Support

• Registration Number: NCT05180812
• Lead Sponsor: Shirley Ryan AbilityLab

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.

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 Timeline

• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Study Start: 2022-03-01
• Primary Completion: 2023-07-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Completion: 2026-07-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group: Gravity Compensation	ExoNet Tuned to Gravity Support	The participants will be wearing the ExoNet device tuned to gravity support.
Control Group: No Gravity Compensation	ExoNet Tuned to Gravity Support	The participants will be wearing the ExoNet device, but it will not be tuned to gravity support.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States