Study to Enhance Motor Acute Recovery With Intensive Training After Stroke "SMARTS2"

Recruiting

Phase N/A Results N/A

Update History

9 Sep '16
A location was updated in Zurich.
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The overall status was updated to "Recruiting" at University of Zurich.
26 Feb '16
The Summary of Purpose was updated.
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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.
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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 5 weeks. We will also look at whether combining the therapy with a non-invasive brain stimulation method called transcranial direct current stimulation (tDCS) can improve arm movements more than therapy alone.
The eligibility criteria were updated.
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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.
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Inclusion Criteria: 1. Age over 21 years 2. Ischemic stroke confirmed by CT or MRI within the previous 5 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. Contraindication to tCDS (history of seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker). 7. Inability to sit in a chair and perform upper limb exercises for one hour at a time. 8. Participation in another upper extremity rehabilitative therapy study or tDCS study during the study period. 9. Terminal illness 10. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
6 May '15
A location was updated in Baltimore.
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The overall status was updated to "Recruiting" at Johns Hopkins University.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Columbia University.
11 Mar '15
The eligibility criteria were updated.
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Inclusion Criteria: 1. Age over 21 years 2. Ischemic stroke confirmed by CT or MRI within the previous 5 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. Contraindication to tCDS (history of seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker). 7. Inability to sit in a chair and perform upper limb exercises for one hour at a time. 8. Participation in another upper extremity rehabilitative therapy study or tDCS study during the study period. 9. Terminal illness 10. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
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Inclusion Criteria: 1. Age 21-65 years 2. Ischemic stroke confirmed by CT or MRI within the previous 5 weeks 3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits 4. Residual unilateral arm weakness at time of enrollment (FM-UE score 6-40) 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 initial assessment 3. Recent botox injection to upper limb or planned botox injection over the course of the study duration 4. Cognitive impairment (Montreal Cognitive Assessment score <21) 5. History of physical or neurological condition that interferes with study procedures or assessment of motor function 6. Contraindication to tDCS (history of seizure, prior electroconvulsive therapy, or deep brain stimulation treatment) 7. Participation in another upper extremity rehabilitative therapy study or tDCS study during the study duration. 8. Terminal illness 9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments -