Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

This study has been terminated.
(Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.)
Sponsor:
Collaborators:
Haukeland University Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Iris Ch. Brunner, University of Bergen
ClinicalTrials.gov Identifier:
NCT00851123
First received: February 23, 2009
Last updated: January 3, 2014
Last verified: January 2014

February 23, 2009
January 3, 2014
February 2009
December 2011   (final data collection date for primary outcome measure)
Action Reach Arm Test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851123 on ClinicalTrials.gov Archive Site
Motor Activity Log [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial

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:

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Behavioral: Modified Constraint-Induced Movement therapy
    Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day.
  • Behavioral: Task-specific bimanual training
    Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own.
  • Experimental: 1. Modified Constraint-Induced Movement therapy
    Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
    Intervention: Behavioral: Modified Constraint-Induced Movement therapy
  • Experimental: 2.Task-specific bimanual training
    Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
    Intervention: Behavioral: Task-specific bimanual training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
January 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00851123
UiB24126
Yes
Iris Ch. Brunner, University of Bergen
University of Bergen
  • Haukeland University Hospital
  • Norwegian Fund for Postgraduate Training in Physiotherapy
Principal Investigator: Iris C. Brunner, MSc University of Bergen
University of Bergen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP