N/A
N=23
Treatment of Chronic Stroke With IpsiHand
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02552368 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Change in Action Research Arm Test (ARAT) Score — 6.2 units on a scale — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IpsiHand Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Action Research Arm Test (ARAT) Score |
6.2 | 0.002 sig |
| SECONDARY Canadian Occupational Performance Measure (COPM) |
1.56; 1.54 | 0.022 sig |
Summary
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 will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.
Eligibility Criteria
Inclusion Criteria
- 6 months post stroke
- Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
- Short Blessed Test Score of 8 or less
- Unstructured Mesulam with 2 or less omissions
Exclusion Criteria
- Dementia
- Severe spasticity in affected upper extremity
- Unilateral Visual Inattention (neglect)
- Contracture(s) in the affected upper extremity
- Botox injections administered within 9 months
- Aphasia which limits effective communication
Data sourced from ClinicalTrials.gov (NCT02552368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.