Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT05965713

Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Conditions: Stroke, Hemiparesis, Spasticity as Sequela of Stroke, Brain Computer Interface, Chronic Stroke Survivors With Plegic Hand

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 109
Sponsor: Neurolutions, Inc.

Location: Washington University in Saint Louis St Louis Missouri

Summary

BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.

Eligibility Criteria

Inclusion Criteria: 1. Adults age (18-85) 2. Adults who sustained a CVA 3. Have upper extremity hemiparesis/hemiplegia 4. 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: 1. 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. 2. 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. 3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. 4. 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. 5. Participants receiving any formal upper extremity therapy will be excluded. 6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. 7. Participants who are pregnant or breast-feeding will be excluded. 8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05965713). StuddyBuddy aggregates publicly available trial information.