Effects of Infant Massage on Development of Down Syndrome Babies

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Procedure: Infant Massage

• Registration Number: NCT03084497
• Lead Sponsor: University of Seville

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2017-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group receiving Infant Massage	Infant Massage	The subjects of this group will receive a total of 5 sessions of Infat Massage.

Primary Outcome Measures

Name	Time	Method
Change from Developmental Age	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)	Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine

Secondary Outcome Measures

Name	Time	Method
Change from Developmental coefficient	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)	Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Sevilla, Spain