Norwegian Constraint-Induced (CI) Therapy Multisite Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group.

Official Title
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Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Procedure: Modified CI therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke). Modified ranking scale 0-2 before admission Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4) Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position. Able to follow a two step command. Mini Mental State examination score of more than 20 (or more than 16 in combination with expressive aphasia) Exclusion Criteria: Modified Rankin Scale > 4 Unable to give informed consent Large hemispatial neglect (more than two cm on the Line Bisection Test) Not expected to survive one year due to other illnesses (eg cardiac, malignancy) Injury or condition in the affected upper extremity that limited use prior to the stroke. Other neurological condition affecting motor function

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Early intervention<br>Modified CI therapy starting between 7 and 28 days post stroke. | Procedure: Modified CI therapy<br>* 10 treatment days 3 hours a day: Shaping exercises 2 hours. Task practice 0,5 hours. Behavioral therapy (Transfer package) 0,5 hour. Encouragement to wear a restraining mitt on the least affected arm for all safe activities.<br>* Other names: Forced use therapy;|
| Active Comparator: Delayed intervention<br>Modified CI Therapy starting 6 months post stroke | Procedure: Modified CI therapy<br>* 10 treatment days 3 hours a day: Shaping exercises 2 hours. Task practice 0,5 hours. Behavioral therapy (Transfer package) 0,5 hour. Encouragement to wear a restraining mitt on the least affected arm for all safe activities.<br>* Other names: Forced use therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor function test |  | 6 months post inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm use accelerometry |  | 6 months | 
| Fugl Meyer Motor Assessment |  | 6 months | 
| Nine hole peg test |  | 6 months | 
| Wolf Motor Function Test |  | 12 months | 
| Arm use accelerometry |  | 12 months | 
| Fugl Meyer Motor Assessment |  | 12 months | 
| Nine Hole Peg Test |  | 12 months |