Stroke
Conditions
Keywords
Stroke, Transcranial direct current stimulation
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 stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.
Interventions
BEHAVIORALDevice-assisted therapy
BEHAVIORALTherapy-based occupational therapy
Sponsors
Columbia University
University of Zurich
James S McDonnell Foundation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 21 years 2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks 3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed) 4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment. 5. Ability to give informed consent and understand the tasks involved.
Exclusion criteria
1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage. 2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention. 3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration. 4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20. 5. 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). 6. Inability to sit in a chair and perform upper limb exercises for one hour at a time. 7. Participation in another upper extremity rehabilitative therapy study during the study period. 8. Terminal illness 9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity (FM-UE) | from baseline to day 3 post-training | Change in arm impairment, measured by FM-UE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity (FM-UE) | from baseline to day 90 post-training | Change in arm impairment, measured by FM-UE |
Countries
Switzerland, United States
Outcome results
None listed