Effect of Baby-CIMT in Infants Younger Than 12 Months
B-CIMT
The Efficacy of Constraint Induced Movement Therapy for Babies (Baby-CIMT) in Infants Below 12 Month With Risk of Developing Unilateral Cerebral Palsy, a Study Protocol of a Randomized Controlled Trial
2 other identifiers
interventional
35
1 country
1
Brief Summary
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 10, 2018
August 1, 2018
3.2 years
May 22, 2013
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hand Assessment for Infants (HAI)
Hand Assessment for Infants (HAI) identify and measure upper limb asymmetry and general manual development from 3-12 month in children at risk of developing cerebral palsy.Even though our Primary Outcome Measure is when children are at one year post term age, we are going to publish results from assessments at earlier ages to measure changes after each intervention period.
12 month post term age
Secondary Outcomes (1)
Alberta Motor Infant Scale
Baseline and12 months post term age
Other Outcomes (1)
To Be a Parent: a questionary
12 monts post preterm
Study Arms (2)
Baby-CIMT
EXPERIMENTALThe infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
baby-massage
EXPERIMENTALThe infants will receive baby massage
Interventions
Baby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys.
For baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage.
Eligibility Criteria
You may qualify if:
- Recruitment criteria of child characteristics
- Age can vary, earliest at 3 months of age and at the latest at 8 months
- Sign of asymmetries from mild to clear and severe asymmetries,
You may not qualify if:
- Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Astrid Lindgren Children Hospital
Stockholm, 171 76, Sweden
Related Publications (1)
Greaves S, Imms C, Krumlinde-Sundholm L, Dodd K, Eliasson AC. Bimanual behaviours in children aged 8-18 months: a literature review to select toys that elicit the use of two hands. Res Dev Disabil. 2012 Jan-Feb;33(1):240-50. doi: 10.1016/j.ridd.2011.09.012. Epub 2011 Oct 11.
PMID: 22093670BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann-Christin Eliasson, professor
Department of Women's and Children's Health, Karolinska Univeristy
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
- professor
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 30, 2013
Study Start
September 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
August 10, 2018
Record last verified: 2018-08