Effect of Baby-CIMT in Infants Younger Than 12 Months (B-CIMT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Hand Assessment for Infants (HAI) [ Time Frame: 12 month post term age ] [ Designated as safety issue: Yes ]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.
- Alberta Motor Infant Scale [ Time Frame: Baseline and12 months post term age ] [ Designated as safety issue: Yes ]Identification of infants who are delayed or deviant in motor development and evaluation of motor development over time. Identifies gross motor performance of an infant compared to norm- referenced sample.
- To Be a Parent: a questionary [ Time Frame: 12 monts post preterm ] [ Designated as safety issue: Yes ]16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
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.
Other Name: Constraint Induced Movement therapy
The infants will receive baby massage
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.
The investigators hypothesis is that Baby-CIMT including intensive specific task oriented training is more preferable than general stimulation which is the assumption for baby massage used in the control group. The intervention protocol is developed at Astrid Lindgren Children hospital, Stockholm Sweden.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864811
|Contact: Ann-Christin Eliasson, firstname.lastname@example.org|
|Astrid Lindgren Children Hospital||Recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Ann-Christin Eliasson, professor 46851777347 email@example.com|
|Principal Investigator:||Ann-Christin Eliasson, professor||Department of Women's and Children's Health, Karolinska Univeristy|