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Active, Not Recruiting

NCT Number: NCT05180812

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ExoNet Tuned to Gravity Support

Device

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.

Primary outcomes

  1. Action Research Arm Test

    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

Secondary outcomes

  1. Fugl-Meyer

    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

  2. Wolf Motor Function Test

    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

  3. Box and Blocks

    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

Other outcomes

  1. Electromyography using Delsys

    Time frame: Treatment phases (week 2 and week 3)

    Delsys sensors will be used to measure change in biceps activity

  2. Kinect

    Time frame: Treatment phases (week 2 and week 3)

    markerless system to collect changes of distribution of motion

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jan 6, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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