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Infants With Down Syndrome on a Different Surface

H

Hacettepe University

Status

Completed

Conditions

Down Syndrome

Treatments

Other: General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day

Study type

Interventional

Funder types

Other

Identifiers

NCT04539535
GO 19/581

Details and patient eligibility

About

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.

Full 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?.

Enrollment

40 patients

Sex

All

Ages

9 to 19 weeks old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

  • Infants whose parents did not want to participate study.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Down syndrome
Experimental group
Description:
We did the General Movements Assessment on standard mattress and experimental mattress in infants with Down syndrome on the same day.
Treatment:
Other: General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day
Typically infants
Experimental group
Description:
We did the General Movements Assessment on standard mattress and experimental mattress in typically infants on the same day.
Treatment:
Other: General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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