Infants With Down Syndrome on a Different Surface

NCT ID: NCT04539535

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-06-30

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?.

Conditions

Down Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Down syndrome

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Different surface

Typically infants

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Different surface

Interventions

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

Different surface

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Weeks
• Maximum Eligible Age: 19 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Bilge Nur Yardımcı Lokmanoğlu

PT, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilge Nur Yardımcı Lokmanoğlu

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 18154890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8857002 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9467693 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31590221 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1705697 (View on PubMed)

Other Identifiers

GO 19/581

Identifier Type: -

Identifier Source: org_study_id