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Infants With Down Syndrome on a Different Surface

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Down Syndrome focused on measuring Down Syndrome, Different Surface, Fidgety Movements, General Movements

Eligibility Criteria

9 Weeks - 19 Weeks (Child)All SexesAccepts 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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Down syndrome

Typically infants

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Prechtl General Movements Assessment
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 Outcome Measures

Full Information

First Posted
August 31, 2020
Last Updated
September 4, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04539535
Brief Title
Infants With Down Syndrome on a Different Surface
Official Title
The Effects of a Different Exteroceptive Experience on the Early Motor Repertoire in Infants With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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?.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down Syndrome, Different Surface, Fidgety Movements, General Movements

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Down syndrome
Arm Type
Experimental
Arm Description
We did the General Movements Assessment on standard mattress and experimental mattress in infants with Down syndrome on the same day.
Arm Title
Typically infants
Arm Type
Experimental
Arm Description
We did the General Movements Assessment on standard mattress and experimental mattress in typically infants on the same day.
Intervention Type
Other
Intervention Name(s)
General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day
Intervention Description
Different surface
Primary Outcome Measure Information:
Title
The Prechtl General Movements Assessment
Description
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.
Time Frame
Between 3 - 5 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Weeks
Maximum Age & Unit of Time
19 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilge Nur Yardımcı Lokmanoğlu
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18154890
Citation
Weijerman ME, van Furth AM, Vonk Noordegraaf A, van Wouwe JP, Broers CJ, Gemke RJ. Prevalence, neonatal characteristics, and first-year mortality of Down syndrome: a national study. J Pediatr. 2008 Jan;152(1):15-9. doi: 10.1016/j.jpeds.2007.09.045. Epub 2007 Nov 19.
Results Reference
background
PubMed Identifier
8857002
Citation
Brandt BR. Impaired tactual perception in children with Down's syndrome. Scand J Psychol. 1996 Sep;37(3):312-6. doi: 10.1111/j.1467-9450.1996.tb00663.x.
Results Reference
background
PubMed Identifier
9467693
Citation
Einspieler C, Prechtl HF, Ferrari F, Cioni G, Bos AF. The qualitative assessment of general movements in preterm, term and young infants--review of the methodology. Early Hum Dev. 1997 Nov 24;50(1):47-60. doi: 10.1016/s0378-3782(97)00092-3.
Results Reference
background
PubMed Identifier
31590221
Citation
Einspieler C, Bos AF, Krieber-Tomantschger M, Alvarado E, Barbosa VM, Bertoncelli N, Burger M, Chorna O, Del Secco S, DeRegnier RA, Huning B, Ko J, Lucaccioni L, Maeda T, Marchi V, Martin E, Morgan C, Mutlu A, Nogolova A, Pansy J, Peyton C, Pokorny FB, Prinsloo LR, Ricci E, Saini L, Scheuchenegger A, Silva CRD, Soloveichick M, Spittle AJ, Toldo M, Utsch F, van Zyl J, Vinals C, Wang J, Yang H, Yardimci-Lokmanoglu BN, Cioni G, Ferrari F, Guzzetta A, Marschik PB. Cerebral Palsy: Early Markers of Clinical Phenotype and Functional Outcome. J Clin Med. 2019 Oct 4;8(10):1616. doi: 10.3390/jcm8101616.
Results Reference
background
PubMed Identifier
1705697
Citation
Linkous LW, Stutts RM. Passive tactile stimulation effects on the muscle tone of hypotonic, developmentally delayed young children. Percept Mot Skills. 1990 Dec;71(3 Pt 1):951-4. doi: 10.2466/pms.1990.71.3.951.
Results Reference
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Infants With Down Syndrome on a Different Surface

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