Clinical trial NCT00851123: Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
Official title: Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
arm paresis
mCIMT
bimanual training
rehabilitation
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2009-02-25
Enrollment: 30
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 the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.

Detailed description: Detailed description:

Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are:

1. To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities.
2. Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training).
3. To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems.

Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.

Eligibility criteria: Inclusion Criteria:

* Upper extremity hemiparesis
* Between 2 and 16 weeks post-stroke
* At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers

Exclusion Criteria:

* Cognitive problems, Mini Mental Status \< 24
* Excessive pain in the paretic extremity
* Major medical problems

Primary outcomes:
measure: Action Reach Arm Test
timeFrame: 3 years
Secondary outcomes:
measure: Motor Activity Log
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Bergen
name: Iris C. Brunner, MSc
role: PRINCIPAL_INVESTIGATOR
References: