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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Hand Assessment for Infants (HAI)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 8 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Baby-CIMT (Behavioral)
baby-massage
The infants will receive baby massage
Intervention: Baby-Massage (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Alberta Motor Infant Scale(Baseline and12 months post term age)
Investigators
Ann-Christin Eliasson
professor
Karolinska Institutet