Status:
WITHDRAWN
IpsiHand System for Rehabilitation of the Arm and Hand After Stroke
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Neurolutions, Inc.
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHa...
Detailed Description
This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors ...
Eligibility Criteria
Inclusion
- Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
- PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
- English speaking
- Intact cognition to provide informed consent
- Intact language skills to comprehend and follow directions
- Experiencing difficulty performing ADLs with affected upper limb
- Upper extremity Botox allowable, but not required
- Botox users must continue regimen at regular intervals for duration of study
- Botox users will provide clinic note for each injection (date, dose, and muscle location)
- Botox + Study Schedule
- At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
- Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures
Exclusion
- Concurrent participation in another study
- Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
- History of neurological disorder other than stroke
- Botox user unable to comply with above noted requirements
- Ongoing physical or occupational therapy addressing the upper limb
- Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
- Cognitive impairment: Short Blessed Test Score 9
- Significant spasticity: Modified Ashworth Scale score 3 at the elbow
- Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
- Insufficient Strength: Motricity Index score for shoulder abduction 18
- Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
- History of cranioplasty
- History of seizure disorder
- No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04123808
Start Date
December 2 2019
End Date
June 30 2020
Last Update
August 5 2020
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