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

Effect of Baby-CIMT in Infants Younger Than 12 Months

Sponsors

Lead sponsor: Karolinska Institutet

Source 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.

Overall Status Completed
Start Date September 2012
Completion Date December 1, 2017
Primary Completion Date December 1, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hand Assessment for Infants (HAI) 12 month post term age
Secondary Outcome
Measure Time Frame
Alberta Motor Infant Scale Baseline and12 months post term age
Enrollment 35
Condition
Intervention

Intervention type: Behavioral

Intervention name: Baby-CIMT

Description: 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.

Arm group label: Baby-CIMT

Other name: Constraint Induced Movement therapy

Intervention type: Behavioral

Intervention name: Baby-Massage

Description: 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.

Arm group label: baby-massage

Eligibility

Criteria:

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

Gender: All

Minimum age: 3 Months

Maximum age: 8 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ann-Christin Eliasson, professor Principal Investigator Department of Women's and Children's Health, Karolinska Univeristy
Location
facility
Astrid Lindgren Children Hospital
Location Countries

Sweden

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Karolinska Institutet

Investigator full name: Ann-Christin Eliasson

Investigator title: professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Baby-CIMT

Arm group type: Experimental

Description: The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.

Arm group label: baby-massage

Arm group type: Experimental

Description: The infants will receive baby massage

Acronym B-CIMT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov