Norwegian Constraint-Induced (CI) Therapy Multisite Trial (NORCIMT)
Primary Purpose
Cerebrovascular Accident
Status
Terminated
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Modified CI therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident
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
Sites / Locations
- Trondheim University Hospital
- University Hospital of North Norway
- Levanger Hospital
- Oslo University hospital, Aker
- Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early intervention
Delayed intervention
Arm Description
Modified CI therapy starting between 7 and 28 days post stroke.
Modified CI Therapy starting 6 months post stroke
Outcomes
Primary Outcome Measures
Wolf Motor function test
Secondary Outcome Measures
Arm use accelerometry
Fugl Meyer Motor Assessment
Nine hole peg test
Wolf Motor Function Test
Arm use accelerometry
Fugl Meyer Motor Assessment
Nine Hole Peg Test
Full Information
NCT ID
NCT00906477
First Posted
May 19, 2009
Last Updated
October 9, 2013
Sponsor
University Hospital of North Norway
Collaborators
Helse Nord
1. Study Identification
Unique Protocol Identification Number
NCT00906477
Brief Title
Norwegian Constraint-Induced (CI) Therapy Multisite Trial
Acronym
NORCIMT
Official Title
Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Helse Nord
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early intervention
Arm Type
Experimental
Arm Description
Modified CI therapy starting between 7 and 28 days post stroke.
Arm Title
Delayed intervention
Arm Type
Active Comparator
Arm Description
Modified CI Therapy starting 6 months post stroke
Intervention Type
Procedure
Intervention Name(s)
Modified CI therapy
Other Intervention Name(s)
Constraint induced movement therapy, Modified constraint induced movement therapy, CIMT, mCIMT, Forced use therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Wolf Motor function test
Time Frame
6 months post inclusion
Secondary Outcome Measure Information:
Title
Arm use accelerometry
Time Frame
6 months
Title
Fugl Meyer Motor Assessment
Time Frame
6 months
Title
Nine hole peg test
Time Frame
6 months
Title
Wolf Motor Function Test
Time Frame
12 months
Title
Arm use accelerometry
Time Frame
12 months
Title
Fugl Meyer Motor Assessment
Time Frame
12 months
Title
Nine Hole Peg Test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyrd Thrane, Cand. San.
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Audny GM Anke, MD, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bent Indredavik, MD, PhD
Organizational Affiliation
Trondheim University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Torunn Askim, PhD
Organizational Affiliation
Norwegian University of Technology and Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roland Stock, MSc
Organizational Affiliation
Trondheim University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trondheim University Hospital
City
Trondheim
State/Province
Sør-Trøndelag
ZIP/Postal Code
N-7006
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
State/Province
Troms
ZIP/Postal Code
N-9038
Country
Norway
Facility Name
Levanger Hospital
City
Levanger
ZIP/Postal Code
N-7600
Country
Norway
Facility Name
Oslo University hospital, Aker
City
Oslo
ZIP/Postal Code
N-0514
Country
Norway
Facility Name
Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
City
Stavern
ZIP/Postal Code
3294
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25398726
Citation
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.
Results Reference
derived
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Norwegian Constraint-Induced (CI) Therapy Multisite Trial
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