Norwegian Constraint-Induced (CI) Therapy Multisite Trial

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00906477

Acronym

NORCIMT

Enrollment

Registered

2009-05-21

Start date

2008-10-31

Completion date

2013-06-30

Last updated

2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

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.

Interventions

PROCEDUREModified 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Wolf Motor function test	6 months post inclusion

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026