Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Device-assisted therapy
* Behavioral: Therapy-based occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device-assisted therapy<br>30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation | Behavioral: Device-assisted therapy<br> <br> |
| Active Comparator: Therapy-based occupational therapy<br>30 hours of conventional occupational therapy that emphasizes task-oriented training. | Behavioral: Therapy-based occupational therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity (FM-UE) | Change in arm impairment, measured by FM-UE | from baseline to day 3 post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity (FM-UE) | Change in arm impairment, measured by FM-UE | from baseline to day 90 post-training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Transcranial direct current stimulation