Status:
TERMINATED
Norwegian Constraint-Induced (CI) Therapy Multisite Trial
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
Helse Nord
Conditions:
Cerebrovascular Accident
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00906477
Start Date
October 1 2008
End Date
June 1 2013
Last Update
October 10 2013
Active Locations (5)
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1
Trondheim University Hospital
Trondheim, Sør-Trøndelag, Norway, N-7006
2
University Hospital of North Norway
Tromsø, Troms, Norway, N-9038
3
Levanger Hospital
Levanger, Norway, N-7600
4
Oslo University hospital, Aker
Oslo, Norway, N-0514