Norwegian Constraint-Induced (CI) Therapy Multisite Trial

Phase 3

Terminated

• Conditions: Cerebrovascular Accident
• Interventions: Procedure: Modified CI therapy

• Registration Number: NCT00906477
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early intervention	Modified CI therapy	Modified CI therapy starting between 7 and 28 days post stroke.
Delayed intervention	Modified CI therapy	Modified CI Therapy starting 6 months post stroke

Primary Outcome Measures

Name	Time	Method
Wolf Motor function test	6 months post inclusion

Secondary Outcome Measures

Name	Time	Method
Nine hole peg test	6 months
Wolf Motor Function Test	12 months
Nine Hole Peg Test	12 months
Arm use accelerometry	12 months
Fugl Meyer Motor Assessment	12 months

Trial Locations

Locations (5)

Trondheim University Hospital; 🇳🇴 Trondheim, Sør-Trøndelag, Norway

Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital; 🇳🇴 Stavern, Norway

Oslo University hospital, Aker; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Troms, Norway

Levanger Hospital; 🇳🇴 Levanger, Norway