Status:
COMPLETED
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Columbia University
University of Zurich
Conditions:
Stroke
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after st...
Eligibility Criteria
Inclusion
- Age over 21 years
- Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
- No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
- Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
- Ability to give informed consent and understand the tasks involved.
Exclusion
- Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
- Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
- Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
- Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
- History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
- Inability to sit in a chair and perform upper limb exercises for one hour at a time.
- Participation in another upper extremity rehabilitative therapy study during the study period.
- Terminal illness
- Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02292251
Start Date
May 1 2015
End Date
April 1 2018
Last Update
August 10 2018
Active Locations (3)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Columbia University
New York, New York, United States, 10032
3
University of Zurich
Zurich, Switzerland