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Effects of Infant Massage on Development of Down Syndrome Babies

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Infant Massage
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Massage, Development

Eligibility Criteria

4 Months - 8 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Seville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group receiving Infant Massage

Group without intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Developmental Age
Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine

Secondary Outcome Measures

Change from Developmental coefficient
Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine

Full Information

First Posted
March 8, 2017
Last Updated
March 14, 2017
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT03084497
Brief Title
Effects of Infant Massage on Development of Down Syndrome Babies
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Massage, Development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group receiving Infant Massage
Arm Type
Experimental
Arm Description
The subjects of this group will receive a total of 5 sessions of Infat Massage.
Arm Title
Group without intervention
Arm Type
No Intervention
Arm Description
The subjects of this group won´t receive any intervention.
Intervention Type
Procedure
Intervention Name(s)
Infant Massage
Intervention Description
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 Outcome Measure Information:
Title
Change from Developmental Age
Description
Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine
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)
Secondary Outcome Measure Information:
Title
Change from Developmental coefficient
Description
Measure by Psychomotor Scale of Developmental in Early Childhood Brunet - Lezine
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PIÑERO PINTO
Organizational Affiliation
University of Sevilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Seville
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Infant Massage on Development of Down Syndrome Babies

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