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Clinical Trials/NCT04539535
NCT04539535CompletedNot Applicable

The Effects of a Different Exteroceptive Experience on the Early Motor Repertoire in Infants With Down Syndrome

Hacettepe University1 site in 1 country40 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
The Prechtl General Movements Assessment

Study Overview

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?.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
9 Weeks to 19 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Down syndrome

Experimental

We did the General Movements Assessment on standard mattress and experimental mattress in infants with Down syndrome on the same day.

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

Typically infants

Experimental

We did the General Movements Assessment on standard mattress and experimental mattress in typically infants on the same day.

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

Outcomes

Primary Outcomes

The Prechtl General Movements Assessment

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bilge Nur Yardımcı Lokmanoğlu

PT, MSc

Hacettepe University

Study Sites (1)

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