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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Ann-Christin Eliasson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01864811
First received: May 22, 2013
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cerebral Palsy
Hemiplegia
Children
Behavioral: Baby-CIMT
Behavioral: Baby-Massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Hand Assessment for Infants (HAI) [ Time Frame: 12 month post term age ] [ Designated as safety issue: Yes ]
    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:
  • Alberta Motor Infant Scale [ Time Frame: Baseline and12 months post term age ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • To Be a Parent: a questionary [ Time Frame: 12 monts post preterm ] [ Designated as safety issue: Yes ]
    16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Baby-CIMT
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 Name: Constraint Induced Movement therapy
Experimental: baby-massage
The infants will receive baby massage
Behavioral: Baby-Massage
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.

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.

  Eligibility

Ages Eligible for Study:   3 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864811

Contacts
Contact: Ann-Christin Eliasson, professor +4685177347 ann-christin.eliasson@ki.se

Locations
Sweden
Astrid Lindgren Children Hospital Recruiting
Stockholm, Sweden, 171 76
Contact: Ann-Christin Eliasson, professor    46851777347    ann-christin.elisson@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Ann-Christin Eliasson, professor Department of Women's and Children's Health, Karolinska Univeristy
  More Information

Publications:
Responsible Party: Ann-Christin Eliasson, professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01864811     History of Changes
Other Study ID Numbers: SFO-V4072/2012, 2011-1522-81929-42
Study First Received: May 22, 2013
Last Updated: May 2, 2014
Health Authority: Sweden: Swedish Research Council

Keywords provided by Karolinska Institutet:
infants
unilateral cerebral pares
hand function
early intervention
constraint induced movement therapy

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014