CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program

Study Overview
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Brief Summary
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The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.

Official Title
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CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)

Conditions
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Chronic Stroke

Intervention / Treatment
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* Other: Standard Occupational Therapy Arm Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single qualifying stroke event as confirmed by CT or MRI At least 1 month post stroke Score of at least 2-/5 on Manual Muscle Test for wrist flexors or extensors, indicating adequate movement to complete robotic device use Able to follow written instructions Exclusion Criteria: Prior arm injury impacting available passive or active range of motion or significant arm pain with movement Underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc. Prior significant drug or alcohol abuse Diagnosed with dementia Pre-stroke baseline modified Rankin Scale (mRS) >3 History of seizure/epilepsy History of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness. Pregnancy Contraindication to MRI or Transcranial Magnetic Stimulation (TMS). Medical instability assessed by the treating stroke physician to participate to the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM-program<br> | Other: Standard Occupational Therapy Arm Exercise Program<br>* Standard exercise program will be provided addressing shoulder, elbow, forearm, wrist, and hand with expectation that participant will complete 3 times a week. Exercise program will be updated at assessment timepoints as needed with change in arm function.<br>* Other names: standard occupational therapy arm exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment | This is a 33 item assessment and each is scored from 0 [unable to perform as instructed] - 2 [faultless performance] with a maximum score of 66. A higher number indicates better arm function. | Baseline, month 4, month 8, month 12, month 16, month 20, month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI). |  | Baseline, month 24 | 
| Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation |  | Baseline, month 4, month 8, month 12, month 16, month 20, month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arm impairment, chronic stroke, stroke