Clinical trial NCT00906477: Norwegian Constraint-Induced (CI) Therapy Multisite Trial
Official title: Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Helse Nord
First posted: 2009-05-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Wolf Motor function test
timeFrame: 6 months post inclusion
Secondary outcomes:
measure: Arm use accelerometry
timeFrame: 6 months
measure: Fugl Meyer Motor Assessment
timeFrame: 6 months
measure: Nine hole peg test
timeFrame: 6 months
measure: Wolf Motor Function Test
timeFrame: 12 months
measure: Arm use accelerometry
timeFrame: 12 months
measure: Fugl Meyer Motor Assessment
timeFrame: 12 months
measure: Nine Hole Peg Test
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Trondheim University Hospital
state: Sør-Trøndelag
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
city: Levanger
country: Norway
facility: Levanger Hospital
city: Oslo
country: Norway
facility: Oslo University hospital, Aker
city: Stavern
country: Norway
facility: Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
Study officials:
affiliation: University Hospital of North Norway
name: Gyrd Thrane, Cand. San.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Audny GM Anke, MD, PhD
role: STUDY_CHAIR
affiliation: Trondheim University Hospital
name: Bent Indredavik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Technology and Science
name: Torunn Askim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trondheim University Hospital
name: Roland Stock, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.