Norwegian Constraint-Induced (CI) Therapy Multisite Trial
NCT ID: NCT00906477
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
47 participants
INTERVENTIONAL
2008-10-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early intervention
Modified CI therapy starting between 7 and 28 days post stroke.
Modified CI therapy
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.
Delayed intervention
Modified CI Therapy starting 6 months post stroke
Modified CI therapy
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.
Interventions
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Modified CI therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Helse Nord
INDUSTRY
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Gyrd Thrane, Cand. San.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Audny GM Anke, MD, PhD
Role: STUDY_CHAIR
University Hospital of North Norway
Bent Indredavik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Trondheim University Hospital
Torunn Askim, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Technology and Science
Roland Stock, MSc
Role: PRINCIPAL_INVESTIGATOR
Trondheim University Hospital
Locations
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Trondheim University Hospital
Trondheim, Sør-Trøndelag, Norway
University Hospital of North Norway
Tromsø, Troms, Norway
Levanger Hospital
Levanger, , Norway
Oslo University hospital, Aker
Oslo, , Norway
Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
Stavern, , Norway
Countries
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References
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Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.
Other Identifiers
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Helse Nord SAT 544-06
Identifier Type: -
Identifier Source: org_study_id