Infants With Down Syndrome on a Different Surface

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Other: General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day

• Registration Number: NCT04539535
• Lead Sponsor: Hacettepe University

Brief Summary

This study included infants with Down syndrome who applied to the Faculty of Physical Therapy and Rehabilitation, Developmental and Early Physiotherapy Unit of Hacettepe University. The project is characterized to investigate whether there is any differences on different surface between infants with Down syndrome and typically infants who are in the same conditions.

Detailed Description

Down syndrome is the most common chromosomal abnormality among the new-borns and characterized by the cognitive deficits, hypotonia, motor developmental and sensory function problems. The somatosensory system disorder such as touch, proprioception, pain and temperature may be seen in these infants and children. There is a delayed peripheral conduction of the stimulus and delayed cerebral processing may cause the abnormal tactile perception response. In the earliest period of life General Movements (GMs), a gestalt-based observation method is one of the most reliable and valid predictors of neurological dysfunction, and it is widely used. GMs occur in age-specific patterns and are described as fidgety movements between from 3 to 5 months in the post-term age. We did the GMs assessment on two different surfaces in the infants with DS and typically infants on the same day, and therefore assumed that determining the fidgety movements and the concurrent movement would enable to us observe the effect of extroceptive stimulation on the fidgety movements and the concurrent movement.

The aim of this study was to investigate the following questions: (i) are fidgety movements and the concurrent motor repertoire of infants with DS depending on different surfaces?, (ii) do fidgety movements and the concurrent motor repertoire change in neurotypical infants depending on the different surface?, and (iii), what are the differences between infants with DS and neurotypical infants?.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Study First Submitted: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Infants aged between 3 and 5 months in both groups
• Infants without any neurological, genetic or metabolic disorder diagnosis in the control group

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Exclusion Criteria

• Infants whose parents did not want to participate study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Down syndrome	General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day	We did the General Movements Assessment on standard mattress and experimental mattress in infants with Down syndrome on the same day.
Typically infants	General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day	We did the General Movements Assessment on standard mattress and experimental mattress in typically infants on the same day.

Primary Outcome Measures

Name	Time	Method
The Prechtl General Movements Assessment	Between 3 - 5 Months	In the earliest period of life General Movements (GMs), a gestalt-based observation method that is widely used, is one of the most reliable and valid predictors of neurological dysfunction. GMs occur in age-specific patterns and are described as fidgety movements from 3 to 5 months in the post-term age.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey