National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke (NCT05965713) | Clinical Trial Compass
CompletedNot Applicable
National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
United States109 participantsStarted 2023-10-01
Plain-language 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 BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form
Timeframe: Assessed at baseline visit and at completion of study
. 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.