Safety and Feasibility of ExoNET

Stroke Clinical Trial

Official title:

Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05180812
• Other study ID #: STU00216062
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 12, 2026

Study information

• Verified date: January 2024
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 12, 2026
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electromyography using Delsys	Delsys sensors will be used to measure change in biceps activity	Treatment phases (week 2 and week 3)
Other	Kinect	markerless system to collect changes of distribution of motion	Treatment phases (week 2 and week 3)
Primary	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	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)
Secondary	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)
Secondary	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)