Clinical trial NCT05131542: Assessment of Hypotonia in Children With Down Syndrome
Official title: Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Hypotonia
Down Syndrome
Muscle, Floppy
CHILD Syndrome
Infant Floppy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Down Syndrome

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
timeFrame: 1 month
measure: Analysis of the reliability of the scale
timeFrame: 1 month
measure: Content validity
timeFrame: 1 month
measure: Empirical validity.
timeFrame: 1 month
measure: Structural validity
timeFrame: In the process of analysis. 1 month to get results.
Secondary outcomes:
measure: Descriptive analysis of the scale
timeFrame: 1 month
measure: Frequency analysis of the items.
timeFrame: 1 month
measure: Analysis of the scale items.
timeFrame: 1 month
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: University of Murcia
Study officials:
affiliation: Unicersity of Murcia
name: Mª Guadalupe de Santos Moreno, MSc PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Unicersity of Murcia
name: Antonia Gómez Conesa, PhD PT
role: STUDY_DIRECTOR
affiliation: Unicersity of Murcia
name: José Antonio López Pina, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/01.pep.0000186506.48500.7c.
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.
citation: 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.
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. doi: 10.1097/PEP.0b013e3180f62bb0.
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.
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.
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.
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.