Status:
COMPLETED
National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
Lead Sponsor:
Neurolutions, Inc.
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BC...
Detailed Description
The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a system that a...
Eligibility Criteria
Inclusion
- Adults age (18-85)
- Adults who sustained a CVA
- Have upper extremity hemiparesis/hemiplegia
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
Exclusion
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
- Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
- Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
- Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
- Participants receiving any formal upper extremity therapy will be excluded.
- Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
- Participants who are pregnant or breast-feeding will be excluded.
- Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT05965713
Start Date
October 1 2023
End Date
October 30 2025
Last Update
December 15 2025
Active Locations (1)
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1
Washington University in Saint Louis
St Louis, Missouri, United States, 63110