Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke, Cerebral Vascular Accident
In brief
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.
Key facts
- Study ID
- NCT06655636
- Run by
- Shirley Ryan AbilityLab
- People needed
- 30
- Starts
- 2024-12-04
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-01-09
Who can join
Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
- Have sustained a single, unilateral stroke at least 8 months prior to enrollment
- Severe to moderate upper extremity impairment (ARAT score 0-30)
- Ability to move their elbow and wrist when supported against gravity
- Cortical stroke with hemiparesis, tactile sensation
- Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct
You may not qualify if…
- Bilateral paresis
- Diffuse/multiple lesion sites or multiple stroke events
- Hemispatial neglect or visual field cut that prevent visual feedback
- Shoulder pain and/or articular rigidity on the upper limb joint
- Severe sensory deficits indicated by the Two-Point Discrimination Test
- Botox injection to the affected upper extremity within the previous 4 months
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands
- Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
- Other neurological issues
- 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 it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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