Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Completed · Not applicable
Conditions studied: Stroke
In brief
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.
Key facts
- Study ID
- NCT04338971
- Run by
- Neurolutions, Inc.
- People needed
- 24
- Starts
- 2017-05-05
- Expected to finish
- 2020-10-09
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 6-months or more post stroke
- Presentation of upper extremity hemiparesis or hemiplegia
- Participants must english speaking
- Demonstrate intact cognition to provide informed consent
- Botox injections are allowed, and must continue regimen at regular intervals throughout the study
- Exclusion Criteria -
- Not active in another clinical study
- Not receiving formal therapy for the upper extremity
- No use of other modalities or technologies to the upper extremity
- Cognitive Impairment: Short Blessed Test Score 9 or above
- Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow
- Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally
- Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use
Where it is running
- Neurolutions — Santa Cruz, California, United States
- Neurolutions — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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