NCT04539535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

August 31, 2020

Last Update Submit

September 4, 2020

Conditions

Down Syndrome

Keywords

Down SyndromeDifferent SurfaceFidgety MovementsGeneral Movements

Outcome Measures

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.

    Between 3 - 5 Months

Study Arms (2)

Down syndrome

EXPERIMENTAL

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

Typically infants

EXPERIMENTAL

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

General Movements Assessment on two different surfaces in infants with DS and typically infants on the same dayOTHER

Different surface

Down syndromeTypically infants

Eligibility Criteria

Age9 Weeks - 19 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Infants whose parents did not want to participate study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 18154890BACKGROUND

  • 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.

    PMID: 8857002BACKGROUND

  • 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.

    PMID: 9467693BACKGROUND

  • 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.

    PMID: 31590221BACKGROUND

  • 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.

    PMID: 1705697BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Bilge Nur Yardımcı Lokmanoğlu

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

June 1, 2019

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)