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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00906477
First received: May 19, 2009
Last updated: May 25, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
 Procedure: Modified CI therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Wolf Motor function test [ Time Frame: 6 months post inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arm use accelerometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fugl Meyer Motor Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nine hole peg test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Wolf Motor Function Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Arm use accelerometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fugl Meyer Motor Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Nine Hole Peg Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Constraint induced movement therapy
  • Modified constraint induced movement therapy
  • CIMT
  • 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:
  • Constraint induced movement therapy
  • Modified constraint induced movement therapy
  • CIMT
  • mCIMT
  • Forced use therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906477

Locations
Norway
Trondheim University Hospital
Trondheim, Sør-Trøndelag, Norway, N-7006
University Hospital of North Norway
Tromsø, Troms, Norway, N-9038
Levanger Hospital
Levanger, Norway, N-7600
Oslo University hospital, Aker
Oslo, Norway, N-0514
Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
Stavern, Norway, 3294
Sponsors and Collaborators
University Hospital of North Norway
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
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00906477     History of Changes
Other Study ID Numbers: Helse Nord SAT 544-06
Study First Received: May 19, 2009
Last Updated: May 25, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013