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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

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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: