Status:
UNKNOWN
MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke
Lead Sponsor:
University Health Network, Toronto
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses ...
Detailed Description
The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses ...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke confirmed by MRI or CT scan
- Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke
- Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand)
- Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19
- Subject is able to follow instructions
- Subject is able to sit and participate in one hour of upper limb therapy
- Anticipated to be discharged home or already at home following conventional inpatient rehabilitation
- Willing to attend outpatient therapy if chronic or late sub-acute
- Subject is able and willing to give written informed consent
- Men and women aged 18 or older
Exclusion
- Global Aphasia
- Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding
- Upper extremity injury or condition prior to stroke that limits the function of the hand or arm
- Life expectancy of less than 12 months due to other illness
- Subject has malignant skin lesion on the affected upper extremity
- Subject has history of seizure disorder and on seizure medications
- Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation)
- Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS)
- Subject has rash or open wound at any potential electrode site
- In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study
- Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study
- Currently enrolled in another upper limb study
- Enrolled in the past six months in a clinical study involving drugs or biologics
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03323632
Start Date
August 1 2014
End Date
December 31 2018
Last Update
October 27 2017
Active Locations (1)
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1
Toronto Rehab Inst, UHN
Toronto, Ontario, Canada, M5G2A2