Assessment of Hypotonia in Children With Down Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Muscle Hypotonia; CHILD Syndrome; Infant Floppy; Muscle, Floppy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30100
    • University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Down Syndrome

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Down Syndrome; Children with down syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of the scale	Analyzing the values of standard deviation, mean, bias and kurtosis.	1 month
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
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

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Principal Investigator: Mª Guadalupe de Santos Moreno, MSc PT, Unicersity of Murcia; Study Director: Antonia Gómez Conesa, PhD PT, Unicersity of Murcia; Study Director: José Antonio López Pina, PhD, Unicersity of Murcia

Publications and helpful links

General Publications

• 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. doi: 10.1097/01.pep.0000186506.48500.7c.
• 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.
• 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.
• 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. doi: 10.1097/PEP.0b013e3180f62bb0.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Manifestations; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome; Muscle Hypotonia
• Other Study ID Numbers: 1999/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No