Norwegian Constraint-Induced (CI) Therapy Multisite Trial "NORCIMT"

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: The study was extended for 2.5 years. A further extension could not be funded. When the study was halted in June 2012, 47 subjects were included.

Conditions

Interventions

  • Modified CI therapy Procedure
    Other Names: Constraint induced movement therapy; Modified constraint induced movement therapy; CIMT; mCIMT; Forced use therapy
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Early intervention
    Description: Modified CI therapy starting between 7 and 28 days post stroke.
    ARM 2: Kind: Experimental
    Label: Delayed intervention
    Description: Modified CI Therapy starting 6 months post stroke

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Wolf Motor function test 6 months post inclusion No
Secondary Arm use accelerometry 6 months No
Secondary Fugl Meyer Motor Assessment 6 months No
Secondary Nine hole peg test 6 months No

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