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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Procedure: Modified CI therapy

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway, N-7600
    • Levanger Hospital
  • Oslo, Norway, N-0514
    • Oslo University Hospital, Aker
  • Stavern, Norway, 3294
    • Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
  • Sør-Trøndelag
    • Trondheim, Sør-Trøndelag, Norway, N-7006
      • Trondheim University Hospital
  • Troms
    • Tromsø, Troms, Norway, N-9038
      • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intervention; Modified CI therapy starting between 7 and 28 days post stroke.	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.; Other Names: CIMT; Constraint induced movement therapy; Modified constraint induced movement therapy; mCIMT; Forced use therapy
Active Comparator: Delayed intervention; Modified CI Therapy starting 6 months post stroke	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.; Other Names: CIMT; Constraint induced movement therapy; Modified constraint induced movement therapy; mCIMT; Forced use therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wolf Motor function test	6 months post inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Helse Nord
• Investigators: Principal Investigator: Gyrd Thrane, Cand. San., University Hospital of North Norway; Study Chair: Audny GM Anke, MD, PhD, University Hospital of North Norway; Principal Investigator: Bent Indredavik, MD, PhD, Trondheim University Hospital; Principal Investigator: Torunn Askim, PhD, Norwegian University of Technology and Science; Principal Investigator: Roland Stock, MSc, Trondheim University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (Estimate): May 21, 2009

Study Record Updates

• Last Update Posted (Estimate): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Helse Nord SAT 544-06