Back to resultsEffect of Baby-CIMT in Infants Younger Than 12 Months (B-CIMT)
Primary Purpose
Cerebral Palsy, Hemiplegia, Children
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Baby-CIMT
Baby-Massage
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring infants, unilateral cerebral pares, hand function, early intervention, constraint induced movement therapy
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
Sites / Locations
- Astrid Lindgren Children Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Baby-CIMT
baby-massage
Arm Description
The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
The infants will receive baby massage
Outcomes
Primary Outcome Measures
Hand Assessment for Infants (HAI)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01864811
Brief Title
Effect of Baby-CIMT in Infants Younger Than 12 Months
Acronym
B-CIMT
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia, Children
Keywords
infants, unilateral cerebral pares, hand function, early intervention, constraint induced movement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baby-CIMT
Arm Type
Experimental
Arm 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 Title
baby-massage
Arm Type
Experimental
Arm Description
The infants will receive baby massage
Intervention Type
Behavioral
Intervention Name(s)
Baby-CIMT
Other Intervention Name(s)
Constraint Induced Movement therapy
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Baby-Massage
Intervention 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.
Primary Outcome Measure Information:
Title
Hand Assessment for Infants (HAI)
Description
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.
Time Frame
12 month post term age
Secondary Outcome Measure Information:
Title
Alberta Motor Infant Scale
Description
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.
Time Frame
Baseline and12 months post term age
Other Pre-specified Outcome Measures:
Title
To Be a Parent: a questionary
Description
16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale
Time Frame
12 monts post preterm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Christin Eliasson, professor
Organizational Affiliation
Department of Women's and Children's Health, Karolinska Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Astrid Lindgren Children Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22093670
Citation
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.
Results Reference
background
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Effect of Baby-CIMT in Infants Younger Than 12 Months
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