Effect of Baby-CIMT in Infants Younger Than 12 Months

Karolinska Institutet35 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy Hemiplegia Children

Interventions

Baby-CIMTBEHAVIORAL

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.

Baby-MassageBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 8 Months

Medical Language ↔ Plain English

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

Locations (1)

Astrid Lindgren Children Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 12 month post term age

Secondary Outcomes

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.

Time frame: Baseline and12 months post term age

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.