Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
Shirley Ryan AbilityLab
30 participants
Dec 4, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria13
- 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
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Interventions
The device spring components will be tuned to produce an assistive supination torque on the forearm.
The device spring components will be tuned to slack springs to serve as a placebo. The user will think they are receiving forces but in reality the device will not be providing any forces.
The device spring components will be tuned to produce a resistive supination torque on the forearm.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06655636