Evaluating a robotic device for helping stroke survivors with arm movement
Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
This study is testing a robotic device that helps stroke survivors move their arms better to see if it can improve their recovery and daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06655636 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, feasibility, and effectiveness of the forearm ExoNET, a passive robotic device designed to assist with forearm supination in individuals who have experienced a stroke. Participants will wear the ExoNET while performing daily activities that require forearm movement, and their muscle activity and range of motion will be monitored using advanced sensors. The study seeks to determine if the device can enhance motor learning and improve rehabilitation outcomes for stroke survivors with upper extremity impairments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-70 who have experienced a single, unilateral stroke at least 8 months prior and have moderate to severe upper extremity impairment.
Not a fit: Patients with bilateral paresis, multiple stroke events, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the rehabilitation process and functional recovery for stroke survivors with upper extremity movement difficulties.
How similar studies have performed: While the approach of using passive robotic devices for rehabilitation is gaining traction, this specific application of the ExoNET is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
2. Have sustained a single, unilateral stroke at least 8 months prior to enrollment
3. Severe to moderate upper extremity impairment (ARAT score 0-30)
4. Ability to move their elbow and wrist when supported against gravity
5. Cortical stroke with hemiparesis, tactile sensation
6. Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct
Exclusion Criteria:
1. Bilateral paresis
2. Diffuse/multiple lesion sites or multiple stroke events
3. Hemispatial neglect or visual field cut that prevent visual feedback
4. Shoulder pain and/or articular rigidity on the upper limb joint
5. Severe sensory deficits indicated by the Two-Point Discrimination Test
6. Botox injection to the affected upper extremity within the previous 4 months
7. Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands
8. Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
9. Other neurological issues
10. Meet any of the contraindications to Delsys Trigno Sensors:
* Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators
* Irritated skin or open wounds
* Silver allergy
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Valentino I Wilson
- Email: viwilso2@uic.edu
- Phone: 630-398-2355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.