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

Norwegian Constraint-Induced (CI) Therapy Multisite Trial

Sponsors

Lead sponsor: University Hospital of North Norway

Collaborator: Helse Nord

Source University Hospital of North Norway
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 intervention group.

Overall Status Terminated
Start Date October 2008
Completion Date June 2013
Primary Completion Date January 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Wolf Motor function test 6 months post inclusion
Secondary Outcome
Measure 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
Enrollment 47
Condition
Intervention

Intervention type: Procedure

Intervention name: Modified CI therapy

Description: 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.

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Trondheim University Hospital | Trondheim, Sør-Trøndelag, N-7006, Norway
University Hospital of North Norway | Tromsø, Troms, N-9038, Norway
Levanger Hospital | Levanger, N-7600, Norway
Oslo University hospital, Aker | Oslo, N-0514, Norway
Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital | Stavern, 3294, Norway
Location Countries

Norway

Verification Date

October 2013

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Early intervention

Arm group type: Experimental

Description: Modified CI therapy starting between 7 and 28 days post stroke.

Arm group label: Delayed intervention

Arm group type: Active Comparator

Description: Modified CI Therapy starting 6 months post stroke

Acronym NORCIMT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov