Infants With Down Syndrome on a Different Surface

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539535
• Other study ID #: GO 19/581
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Weeks to 19 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Brandt BR. Impaired tactual perception in children with Down's syndrome. Scand J Psychol. 1996 Sep;37(3):312-6. — View Citation

Einspieler C, Bos AF, Krieber-Tomantschger M, Alvarado E, Barbosa VM, Bertoncelli N, Burger M, Chorna O, Del Secco S, DeRegnier RA, Hüning B, Ko J, Lucaccioni L, Maeda T, Marchi V, Martín E, Morgan C, Mutlu A, Nogolová 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, Viñals 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). pii: E1616. doi: 10.3390/jcm8101616. — View Citation

Einspieler C, Prechtl HF, Bos AF, Ferrari F, Cioni G. Prechtl's method on the qualitative assessment of general movements in preterm, term and young infants. London: MacKeith Press; 2004. distributed by Cambridge University Press

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. — View 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. Epub 2007 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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