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

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ClinicalTrials.gov Identifier: NCT01864811
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ann-Christin Eliasson, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE May 22, 2013
First Posted Date  ICMJE May 30, 2013
Last Update Posted Date August 10, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01864811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Baby-CIMT in Infants Younger Than 12 Months
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Palsy
  • Hemiplegia
  • Children
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Baby-CIMT
  • Experimental: baby-massage
    The infants will receive baby massage
    Intervention: Behavioral: Baby-Massage
Publications * Greaves S, Imms C, Krumlinde-Sundholm L, Dodd K, Eliasson AC. Bimanual behaviours in children aged 8-18 months: a literature review to select toys that elicit the use of two hands. Res Dev Disabil. 2012 Jan-Feb;33(1):240-50. doi: 10.1016/j.ridd.2011.09.012. Epub 2011 Oct 11. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
35
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
40
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 8 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864811
Other Study ID Numbers  ICMJE SFO-V4072/2012
2011-1522-81929-42 ( Other Grant/Funding Number: Swedish Research Counsil )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ann-Christin Eliasson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ann-Christin Eliasson, professor Department of Women's and Children's Health, Karolinska Univeristy
PRS Account Karolinska Institutet
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP