Assessment of Hypotonia in Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:

Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131542
• Other study ID #: 1999/2018
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.

Description:

Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months to 8 Years

Eligibility

Inclusion Criteria:

• Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old

Exclusion Criteria:

• Other hypotonic syndromes

Related Conditions & MeSH terms

• CHILD Syndrome
• Down Syndrome
• Infant Floppy
• Muscle Hypotonia
• Syndrome

Locations

Country	Name	City	State
Spain	University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Goo M, Tucker K, Johnston LM. Muscle tone assessments for children aged 0 to 12 years: a systematic review. Dev Med Child Neurol. 2018 Jul;60(7):660-671. doi: 10.1111/dmcn.13668. Epub 2018 Feb 6. Review. — View Citation

Govender P, Joubert RWE. 'Toning' up hypotonia assessment: A proposal and critique. Afr J Disabil. 2016 May 26;5(1):231. doi: 10.4102/ajod.v5i1.231. eCollection 2016. — View Citation

Govender P, Joubert RWE. Evidence-Based Clinical Algorithm for Hypotonia Assessment: To Pardon the Errs. Occup Ther Int. 2018 Apr 24;2018:8967572. doi: 10.1155/2018/8967572. eCollection 2018. Review. — View Citation

Martin K, Inman J, Kirschner A, Deming K, Gumbel R, Voelker L. Characteristics of hypotonia in children: a consensus opinion of pediatric occupational and physical therapists. Pediatr Phys Ther. 2005 Winter;17(4):275-82. — View Citation

Martin K, Kaltenmark T, Lewallen A, Smith C, Yoshida A. Clinical characteristics of hypotonia: a survey of pediatric physical and occupational therapists. Pediatr Phys Ther. 2007 Fall;19(3):217-26. — View Citation

Naidoo P, Joubert RW. Consensus on hypotonia via Delphi process. Indian J Pediatr. 2013 Aug;80(8):641-50. doi: 10.1007/s12098-013-1018-7. Epub 2013 May 17. — View Citation

Naidoo P. Development of an evidence-based clinical algorithm for practice in hypotonia assessment: a proposal. JMIR Res Protoc. 2014 Dec 5;3(4):e71. doi: 10.2196/resprot.3581. — View Citation

Reus L, van Vlimmeren LA, Staal JB, Janssen AJ, Otten BJ, Pelzer BJ, Nijhuis-van der Sanden MW. Objective evaluation of muscle strength in infants with hypotonia and muscle weakness. Res Dev Disabil. 2013 Apr;34(4):1160-9. doi: 10.1016/j.ridd.2012.12.015. Epub 2013 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.	A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.	1 month
Primary	Analysis of the reliability of the scale	Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed	1 month
Primary	Content validity	It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.	1 month
Primary	Empirical validity.	The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.	1 month
Primary	Structural validity	Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.	In the process of analysis. 1 month to get results.
Secondary	Descriptive analysis of the scale	Analyzing the values of standard deviation, mean, bias and kurtosis.	1 month
Secondary	Frequency analysis of the items.	Frequency with which 0 (less hypotonia), 1 or 2 (greater hypotonia) each item of the scale has been scored.	1 month
Secondary	Analysis of the scale items.	An analysis of standard deviation, mean, correlation and Cronbach's alpha was performed for each item that made up the scale.	1 month

External Links

•   The American Academy for Cerebral Palsy and Developmental Medicine, develops a care pathway for therapeutic interventions for central hypotonia