Assessment of Hypotonia in Children With Down Syndrome

NCT05131542 | Completed DMC

• 1 other identifier: 1999/2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Hypotonia; Down Syndrome; Muscle, Floppy; CHILD Syndrome; Infant Floppy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Descriptive analysis of the scale

  1 month

• Frequency analysis of the items.

  1 month

• Analysis of the scale items.

  1 month

Study Arms (1)

Down Syndrome

Children with down syndrome

Eligibility Criteria

• Age: 7 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Down Syndrome

You may qualify if:

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

You may not qualify if:

• Other hypotonic syndromes

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

University of Murcia

Murcia, 30100, Spain

Location

Related Publications (8)

• 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.

  PMID: 16357683 BACKGROUND

• 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.

  PMID: 28730054 BACKGROUND

• 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.

  PMID: 29405265 BACKGROUND

• 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.

  PMID: 17700351 BACKGROUND

• 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.

  PMID: 29853815 BACKGROUND

• 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.

  PMID: 23681830 BACKGROUND

• 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.

  PMID: 23380578 BACKGROUND

• 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.

  PMID: 25485571 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Muscle Hypotonia; Down Syndrome; Congenital Hemidysplasia with Ichthyosiform Erythroderma and Limb Defects

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Mª Guadalupe de Santos Moreno, MSc PT

  Unicersity of Murcia

  PRINCIPAL INVESTIGATOR

• Antonia Gómez Conesa, PhD PT

  Unicersity of Murcia

  STUDY DIRECTOR

• José Antonio López Pina, PhD

  Unicersity of Murcia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 23, 2021
• Study Start: April 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)