Norwegian Constraint-Induced (CI) Therapy Multisite Trial

Cerebrovascular Accident Clinical Trial

— NORCIMT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00906477
• Other study ID #: Helse Nord SAT 544-06
• Status: Terminated
• Phase: Phase 3
• First received: May 19, 2009
• Last updated: October 9, 2013
• Start date: October 2008
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Norway	Levanger Hospital	Levanger
Norway	Oslo University hospital, Aker	Oslo
Norway	Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital	Stavern
Norway	University Hospital of North Norway	Tromsø	Troms
Norway	Trondheim University Hospital	Trondheim	Sør-Trøndelag

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Helse Nord

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor function test		6 months post inclusion	No
Secondary	Arm use accelerometry		6 months	No
Secondary	Fugl Meyer Motor Assessment		6 months	No
Secondary	Nine hole peg test		6 months	No
Secondary	Wolf Motor Function Test		12 months	No
Secondary	Arm use accelerometry		12 months	No
Secondary	Fugl Meyer Motor Assessment		12 months	No
Secondary	Nine Hole Peg Test		12 months	No