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Effect of Baby-CIMT in Infants Younger Than 12 Months (B-CIMT)

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

Cerebral Palsy
Children
Hemiplegia

Treatments

Behavioral: Baby-CIMT
Behavioral: Baby-Massage

Study type

Interventional

Funder types

Other

Identifiers

NCT01864811
2011-1522-81929-42 (Other Grant/Funding Number)
SFO-V4072/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

3 to 8 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

35 participants in 2 patient groups

Baby-CIMT
Experimental group
Description:
The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
Treatment:
Behavioral: Baby-CIMT
baby-massage
Experimental group
Description:
The infants will receive baby massage
Treatment:
Behavioral: Baby-Massage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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