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NCT Number: NCT03084497

Effects of Infant Massage on Development of Down Syndrome Babies

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

4 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infant Massage

Procedure

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.

Primary outcomes

  1. Change from Developmental Age

    Time frame: 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 outcomes

  1. Change from Developmental coefficient

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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