Effects of Infant Massage on Development of Down Syndrome Babies

Study Overview
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Brief Summary
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The aim of ths study is to know the effects of infant massage in the maturation of the baby with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will be used to measure the maturational development of the baby with Down syndrome . Investigators will analyze two groups of intervention, the experimental group, in which parents will participate and will apply the knowledge learned in the course of Infant Massage and control, which does not receive the Infant Massage course during the study. Babies in both groups will be evaluated twice, at the beginning of the intervention (pretest) and end it after five weeks (posttest). The study population consists of 32 babies with Down syndrome between 4 and 8 months old.

Detailed Description
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In this study, the investigators will compare the maturational development of the experimental group Down syndrome babies (will receive infant massage in the period between the two measurements) with the maturational development of the control group Down syndrome babies (will receive infant massage after two measurements). Assess both the development partial motor, cognitive, language and social, and also the maturational development global. Finally, measure also the ratio of development, both in the pretest as on the posttest. The test that will use to measure the development of them babies is the scale of development psychomotor of her first childhood Brunet-Lezine-R. The babies of the study may hay between 4 and 8 months old.

Official Title
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Effects and Effectiveness of Infant Massage in Motor, Cognitive, Language and Social Developmental in Babies With Syndrome of Down Aged Between 4 and 8 Months

Conditions
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Down Syndrome

Intervention / Treatment
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* Procedure: Infant Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Babies with Down Syndrome that received Early Attention. Exclusion Criteria: Babies with Down syndrome: With associated pathology. Adopted. Have received infant massage course.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group receiving Infant Massage<br>The subjects of this group will receive a total of 5 sessions of Infat Massage. | Procedure: Infant Massage<br>* The first day, investigators will make the initial assessment of the baby through Psychomotor Development Scale of Early Childhood Brunet- Lézine. Participants will keep the sessions early attention and will participate in the course of Infant Massage, which develop for 5 weeks. Infant Massage course will take place with families and is based on the methodology and program of the International Association of Infant Massage ( IAIM ), created by Vimala McClure. The course will consist of 5 sessions (one per week) approximately 90 minutes. Parents will practice everyday the movements learned during the time of the study. When the course of Infant Massage finished, Investigators will conduct the final evaluation of the baby, the same way as in the initial evaluation.<br>|
| No Intervention: Group without intervention<br>The subjects of this group won´t receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Developmental Age | Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine | At the start of the study (before the first session of Infant Massage and before the asignation of a group) and after the last session of Infant Massage Course (5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Developmental coefficient | Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine | At the start of the study (before the first session of Infat Massage and before the asignation of the group) and after the last session of Infat Massage Course (5 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Development