Assessment of Hypotonia in Children With Down Syndrome

NCT ID: NCT05131542

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-01-15

Brief Summary

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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

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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.

Conditions

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Muscle Hypotonia Down Syndrome Muscle, Floppy CHILD Syndrome Infant Floppy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Down Syndrome

Children with down syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

7 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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María Guadalupe de Santos Moreno

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mª Guadalupe de Santos Moreno, MSc PT

Role: PRINCIPAL_INVESTIGATOR

Unicersity of Murcia

Antonia Gómez Conesa, PhD PT

Role: STUDY_DIRECTOR

Unicersity of Murcia

José Antonio López Pina, PhD

Role: STUDY_DIRECTOR

Unicersity of Murcia

Locations

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University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 16357683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28730054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29405265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17700351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29853815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23681830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23380578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25485571 (View on PubMed)

Related Links

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http://www.aacpdm.org/publications/care-pathways/central-hypotonia

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

Other Identifiers

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1999/2018

Identifier Type: -

Identifier Source: org_study_id

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