Status:
NOT_YET_RECRUITING
Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors
Lead Sponsor:
Neurolutions, Inc.
Conditions:
Stroke
Hemiparesis After Stroke
Eligibility:
All Genders
18-85 years
Brief Summary
This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessin...
Detailed Description
IpsiHand® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facili...
Eligibility Criteria
Inclusion
- Adult age 18-85 years.
- Diagnosis of stroke six or more months prior with upper extremity weakness.
- Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.
Exclusion
- Severe cognitive impairment that would impede utilization of IpsiHand®
- Any contraindications to IpsiHand® device use
- Inability to comprehend English
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07147881
Start Date
September 1 2025
End Date
January 1 2028
Last Update
August 29 2025
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