An interventional study of Infant Massage in Down Syndrome, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 4 Months to 8 Months. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
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.
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 32 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Babies with Down syndrome:
The subjects of this group will receive a total of 5 sessions of Infat Massage.
Procedure: Infant Massage
The subjects of this group won´t receive any intervention.
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.
Change from Developmental Age
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)
Change from Developmental coefficient
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)
Plan to share: No
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University of Seville