Norwegian Constraint-Induced (CI) Therapy Multisite Trial

Overview

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.

Full Title of Study: “Intensive Training of Arm and Hand Function in People With Stroke – A Randomized Controlled Multisite Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2013

Interventions

  • Procedure: 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.

Arms, Groups and Cohorts

  • Experimental: Early intervention
    • Modified CI therapy starting between 7 and 28 days post stroke.
  • Active Comparator: Delayed intervention
    • Modified CI Therapy starting 6 months post stroke

Clinical Trial Outcome Measures

Primary Measures

  • Wolf Motor function test
    • Time Frame: 6 months post inclusion

Secondary Measures

  • Arm use accelerometry
    • Time Frame: 6 months
  • Fugl Meyer Motor Assessment
    • Time Frame: 6 months
  • Nine hole peg test
    • Time Frame: 6 months
  • Wolf Motor Function Test
    • Time Frame: 12 months
  • Arm use accelerometry
    • Time Frame: 12 months
  • Fugl Meyer Motor Assessment
    • Time Frame: 12 months
  • Nine Hole Peg Test
    • Time Frame: 12 months

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital of North Norway
  • Collaborator
    • Helse Nord
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gyrd Thrane, Cand. San., Principal Investigator, University Hospital of North Norway
    • Audny GM Anke, MD, PhD, Study Chair, University Hospital of North Norway
    • Bent Indredavik, MD, PhD, Principal Investigator, Trondheim University Hospital
    • Torunn Askim, PhD, Principal Investigator, Norwegian University of Technology and Science
    • Roland Stock, MSc, Principal Investigator, Trondheim University Hospital

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