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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-1522-81929-42 | Other Grant/Funding Number | Swedish Research Counsil |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baby-CIMT | Experimental | The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys. |
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| baby-massage | Experimental | The infants will receive baby massage |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month post term age |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and12 months post term age |
| Measure | Description | Time Frame |
|---|---|---|
| To Be a Parent: a questionary | 16 statement as both parents has to fill in. they have to agree on the statement based on a 6-grading scale | 12 monts post preterm |
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
Exclusion Criteria:
Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Christin Eliasson, professor | Department of Women's and Children's Health, Karolinska Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astrid Lindgren Children Hospital | Stockholm | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22093670 | Background | 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. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000098483 | Constraint Induced Movement Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 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. |
|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |