NCT06655636 Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
| NCT ID | NCT06655636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-12-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06655636 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06655636 currently recruiting?
Yes, NCT06655636 is actively recruiting participants. Contact the research team at viwilso2@uic.edu for enrollment information.
Where is the NCT06655636 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06655636 clinical trial?
NCT06655636 is sponsored by Shirley Ryan AbilityLab. The trial plans to enroll 30 participants.
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