Effect of Baby-CIMT in Infants Younger Than 12 Months

Not Applicable

Completed

• Conditions: Hemiplegia; Children; Cerebral Palsy
• Interventions: Behavioral: Baby-CIMT; Behavioral: Baby-Massage

• Registration Number: NCT01864811
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-30
• Primary Completion: 2015-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baby-CIMT	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.
baby-massage	Baby-Massage	The infants will receive baby massage

Primary Outcome Measures

Name	Time	Method
Hand Assessment for Infants (HAI)	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

Name	Time	Method
Alberta Motor Infant Scale	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.

Trial Locations

Locations (1)

Astrid Lindgren Children Hospital; 🇸🇪 Stockholm, Sweden