Effect of Baby-CIMT in Infants Younger Than 12 Months

NCT ID: NCT01864811

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Hemiplegia Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Baby-CIMT

Intervention Type 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.

baby-massage

The infants will receive baby massage

Group Type EXPERIMENTAL

Baby-Massage

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Constraint Induced Movement therapy

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ann-Christin Eliasson

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann-Christin Eliasson, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Women's and Children's Health, Karolinska Univeristy

Locations

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Astrid Lindgren Children Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 22093670 (View on PubMed)

Other Identifiers

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2011-1522-81929-42

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SFO-V4072/2012

Identifier Type: -

Identifier Source: org_study_id

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