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

This study has been completed.
Information provided by (Responsible Party):
Ann-Christin Eliasson, Karolinska Institutet Identifier:
First received: May 22, 2013
Last updated: March 7, 2016
Last verified: March 2016
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 Intervention
Cerebral Palsy Hemiplegia Children Behavioral: Baby-CIMT Behavioral: Baby-Massage

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Ann-Christin Eliasson, Karolinska Institutet:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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

Enrollment: 35
Study Start Date: September 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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

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Please refer to this study by its identifier: NCT01864811

Astrid Lindgren Children Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Ann-Christin Eliasson, professor Department of Women's and Children's Health, Karolinska Univeristy
  More Information

Responsible Party: Ann-Christin Eliasson, professor, Karolinska Institutet Identifier: NCT01864811     History of Changes
Other Study ID Numbers: SFO-V4072/2012
2011-1522-81929-42 ( Other Grant/Funding Number: Swedish Research Counsil )
Study First Received: May 22, 2013
Last Updated: March 7, 2016

Keywords provided by Ann-Christin Eliasson, Karolinska Institutet:
unilateral cerebral pares
hand function
early intervention
constraint induced movement therapy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on September 19, 2017