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
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Modified Constraint-Induced Movement therapy
Behavioral: Task-specific bimanual training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Action Reach Arm Test [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor Activity Log [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Modified Constraint-Induced Movement therapy
Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
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.
Experimental: 2.Task-specific bimanual training
Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851123

Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Principal Investigator: Iris C. Brunner, MSc University of Bergen
  More Information

No publications provided

Responsible Party: Iris Ch. Brunner, Research fellow, MSc, University of Bergen
ClinicalTrials.gov Identifier: NCT00851123     History of Changes
Other Study ID Numbers: UiB24126
Study First Received: February 23, 2009
Last Updated: January 3, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Bergen:
Stroke
arm paresis
mCIMT
bimanual training
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014