Effects of Infant Massage on Development of Down Syndrome Babies

Down Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084497
• Other study ID #: USeville - EPinto
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: March 14, 2017
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 8 Months

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Procedure:
• Infant Massage
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.

Locations

Country	Name	City	State
Spain	University of Seville	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)