Study Stopped
Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Feb 2009
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 6, 2014
January 1, 2014
2.8 years
February 23, 2009
January 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Action Reach Arm Test
3 years
Secondary Outcomes (1)
Motor Activity Log
3 years
Study Arms (2)
1. Modified Constraint-Induced Movement therapy
EXPERIMENTALModified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
2.Task-specific bimanual training
EXPERIMENTALTask-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cognitive problems, Mini Mental Status \< 24
- Excessive pain in the paretic extremity
- Major medical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Haukeland University Hospitalcollaborator
- Norwegian Fund for Postgraduate Training in Physiotherapycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iris C. Brunner, MSc
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research fellow, MSc
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
January 6, 2014
Record last verified: 2014-01