Constraint Induced Movement Therapy (CIMT) in Babies Home Program
1 other identifier
interventional
30
1 country
1
Brief Summary
The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
1 active site
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
First Submitted
Initial submission to the registry
July 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 21, 2011
June 1, 2010
7 months
July 27, 2010
June 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Assistive Hand Assessment
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities
after two months of treatment
Study Arms (2)
Experimental CIMT
EXPERIMENTALTwo month home program that includes restricting the non hemiplegic hand an hour a day during play
Active Play
ACTIVE COMPARATORTwo month home program that includes active use of hemiplegic hand during play one hour a day
Interventions
soft mitten worn on the non hemiplegic hand
Eligibility Criteria
You may qualify if:
- Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy
You may not qualify if:
- Epilepsy not treated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ShaareZMC
Jerusalem, Israel
Related Publications (2)
Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.
PMID: 30760393DERIVEDChamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.
PMID: 30307370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 27, 2010
First Posted
October 5, 2010
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
June 21, 2011
Record last verified: 2010-06