Effect of Baby-CIMT in Infants Younger Than 12 Months (B-CIMT)
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|ClinicalTrials.gov Identifier: NCT01864811|
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Hemiplegia Children||Behavioral: Baby-CIMT Behavioral: Baby-Massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 1, 2015|
|Actual Study Completion Date :||December 1, 2017|
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.
- Hand Assessment for Infants (HAI) [ Time Frame: 12 month post term age ]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 ]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 ]16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864811
|Astrid Lindgren Children Hospital|
|Stockholm, Sweden, 171 76|
|Principal Investigator:||Ann-Christin Eliasson, professor||Department of Women's and Children's Health, Karolinska Univeristy|