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Effect of Baby-CIMT in Infants Younger Than 12 Months (B-CIMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01864811
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Ann-Christin Eliasson, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Hemiplegia Children Behavioral: Baby-CIMT Behavioral: Baby-Massage Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2012
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Baby-CIMT
The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
Behavioral: Baby-CIMT
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

Experimental: baby-massage
The infants will receive baby massage
Behavioral: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:1. A neonatal history of different origin of events affecting the brain, preterm children with predominantly unilateral hemorrhage, venous infarction or with matter lesion or pre, perinatal or early postnatal stroke or Infants referred to the hospital/rehabilitation centers/specialists with signs of asymmetries before 8 month of age, likely to be diagnosed with unilateral cerebral palsy at later age.

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,

Exclusion Criteria:

Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month

Information from the National Library of Medicine

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 identifier (NCT number): NCT01864811

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Astrid Lindgren Children Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Ann-Christin Eliasson, professor Department of Women's and Children's Health, Karolinska Univeristy
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Responsible Party: Ann-Christin Eliasson, professor, Karolinska Institutet Identifier: NCT01864811    
Other Study ID Numbers: SFO-V4072/2012
2011-1522-81929-42 ( Other Grant/Funding Number: Swedish Research Counsil )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Ann-Christin Eliasson, Karolinska Institutet:
unilateral cerebral pares
hand function
early intervention
constraint induced movement therapy
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations