Effects of Infant Massage on Development of Down Syndrome Babies

NCT ID: NCT03084497

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group receiving Infant Massage

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

Group Type: EXPERIMENTAL

Infant Massage

Intervention Type: 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 without intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Elena Piñero Pinto

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PIÑERO PINTO

Role: PRINCIPAL_INVESTIGATOR

University of Sevilla

Locations

University of Seville

Seville, , Spain

Countries

Spain

Other Identifiers

USeville - EPinto

Identifier Type: -

Identifier Source: org_study_id