Effects of Infant Massage on Development of Down Syndrome Babies

NCT03084497 | Completed

• 1 other identifier: USeville - EPinto
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Massage; Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Group receiving Infant Massage

EXPERIMENTAL

The subjects of this group will receive a total of 5 sessions of Infat Massage.

Procedure: Infant Massage

Group without intervention

NO INTERVENTION

The subjects of this group won´t receive any intervention.

Interventions

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.

Group receiving Infant Massage

Eligibility Criteria

• Age: 4 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies with Down Syndrome that received Early Attention.

You may not qualify if:

• Babies with Down syndrome:
• With associated pathology.
• Adopted.
• Have received infant massage course.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville

Seville, Spain

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• PIÑERO PINTO

  University of Sevilla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)