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Completed

NCT Number: NCT01864811

Effect of Baby-CIMT in Infants Younger Than 12 Months

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Children Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astrid Lindgren Children Hospital

Stockholm, 171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby-CIMT

Behavioral

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.

Other names: Constraint Induced Movement therapy

Baby-Massage

Behavioral

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.

Primary outcomes

  1. 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

  1. Alberta Motor Infant Scale

    Time frame: 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.

Other outcomes

  1. To Be a Parent: a questionary

    Time frame: 12 monts post preterm

    16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: B-CIMT

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
May 30, 2013
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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