Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors

Launched by SHIRLEY RYAN ABILITYLAB · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special device called the ExoNET, which is designed to help stroke survivors improve the movement of their forearms. The ExoNET is a passive robotic device that uses springs to assist in a movement called supination, which is when you turn your palm up. The goal of the study is to make sure that this device is safe and effective for adults who have had a stroke, particularly those with difficulty moving their upper arms.

To participate in the trial, you need to be between the ages of 40 and 70 and have experienced a single stroke at least 8 months ago. You should have moderate to severe difficulties moving your arm but still be able to move your elbow and wrist with some support. The study is open to all genders, and those who meet the criteria will be able to try the ExoNET in a supportive environment. Participants will be monitored to see how well they can use the device and whether it helps improve their arm movement. It’s important to note that certain medical conditions may exclude someone from participating, such as having multiple strokes or other neurological issues.

Gender

ALL

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