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CompletedNCT04539535Updated Sep 7, 2020

Infants With Down Syndrome on a Different Surface

An interventional study of General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day in Down Syndrome, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 9 Weeks to 19 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-07.

Sponsored by Hacettepe University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
9 Weeks to 19 Weeks
Sex
All
01

Study 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.

Read the 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?.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down Syndrome
  • Different Surface
  • Fidgety Movements
  • General Movements
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 40 is above the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Weeks to 19 Weeks
Sexes eligible
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

Exclusion Criteria:

  • Infants whose parents did not want to participate study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Down syndrome

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

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

  • Experimental
    Typically infants

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

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

Interventions

  • OtherGeneral Movements Assessment on two different surfaces in infants with DS and typically infants on the same day

    Different surface

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Between 3 - 5 Months

07

Study locations

1 site
  • Hacettepe University
    Ankara, 06100, Turkey
08

References and documents

Publications

  • 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. PubMed 18154890 ↗
  • 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. PubMed 8857002 ↗
  • 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. PubMed 9467693 ↗
  • 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. PubMed 31590221 ↗
  • 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. PubMed 1705697 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04539535
Lead sponsor
Hacettepe University
Responsible party
Bilge Nur Yardımcı Lokmanoğlu (PT, MSc, Hacettepe University) — Principal investigator
First posted
Sep 7, 2020
Start date
Jun 1, 2019
Primary completion
Dec 31, 2019
Completion
Jun 30, 2020
Last update
Sep 7, 2020

Study contacts

Bilge Nur Yardımcı Lokmanoğlu
principal investigator · Hacettepe University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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