Effect of Baby-CIMT in Infants Younger Than 12 Months

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cerebral Palsy, Hemiplegia, Children

Intervention / Treatment
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* Behavioral: Baby-CIMT
* Behavioral: Baby-Massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baby-CIMT<br>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<br>* 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.<br>* Other names: Constraint Induced Movement therapy;|
| Experimental: baby-massage<br>The infants will receive baby massage | Behavioral: Baby-Massage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alberta Motor Infant Scale | 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. | Baseline and12 months post term age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants, unilateral cerebral pares, hand function, early intervention, constraint induced movement therapy