Clinical trial NCT05649436: Assessment of Developmental Status and Locomotor Balance in Healthy Children.
Official title: Assessment of Developmental Status and Locomotor Balance in Healthy Children. A Normative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development, Child
Keywords: balance
developmental milestone
locomotor balance
proprioception
ages and stages questionnaire
timed up and go test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: daycare centers primary schools

Brief summary: The aim of this study is to assess developmental milestones and balance in children in Pakistan. We are using Ages and Stages Questionnaire for developmental milestones and Timed up and Go test for balance.

Detailed description: We will visit daycare centers and primary schools to collect data and compare them to cut off values provided in the scale. After scoring each domain, scores will tell whether child needs further investigation or he is healthy.

Eligibility criteria: Inclusion Criteria:

* 2 months to 5 years of age
* Families living in urban areas
* Families with financial stability when the child was growing

Exclusion Criteria:

* Multiple Pregnancies of mother
* A known history of diabetes of mother
* Uneducated Mother
* A known history of psychological problems of parents
* Impaired Cognition of Children
* Deafness or Blindness of Children
* Children with 36 weeks or less gestational periods

Primary outcomes:
measure: Ages and Stages Questionnaire
timeFrame: last one week
measure: Timed Up and Go test
timeFrame: last one week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Govt College of Technology for women, Day care center
state: Punjab
Study officials:
affiliation: Riphah International University
name: shabana ashraf, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Agarwal PK, Shi L, Daniel LM, Yang PH, Khoo PC, Quek BH, Zheng Q, Rajadurai VS. Prospective evaluation of the Ages and Stages Questionnaire 3rd Edition in very-low-birthweight infants. Dev Med Child Neurol. 2017 May;59(5):484-489. doi: 10.1111/dmcn.13307. Epub 2016 Nov 24.
citation: Park JH, Hwangbo G. The effect of trunk stabilization exercises using a sling on the balance of patients with hemiplegia. J Phys Ther Sci. 2014 Feb;26(2):219-21. doi: 10.1589/jpts.26.219. Epub 2014 Feb 28.
citation: Verbecque E, Vereeck L, Boudewyns A, Van de Heyning P, Hallemans A. A Modified Version of the Timed Up and Go Test for Children Who Are Preschoolers. Pediatr Phys Ther. 2016 winter;28(4):409-15. doi: 10.1097/PEP.0000000000000293.
citation: Villar J, Fernandes M, Purwar M, Staines-Urias E, Di Nicola P, Cheikh Ismail L, Ochieng R, Barros F, Albernaz E, Victora C, Kunnawar N, Temple S, Giuliani F, Sandells T, Carvalho M, Ohuma E, Jaffer Y, Noble A, Gravett M, Pang R, Lambert A, Bertino E, Papageorghiou A, Garza C, Stein A, Bhutta Z, Kennedy S. Neurodevelopmental milestones and associated behaviours are similar among healthy children across diverse geographical locations. Nat Commun. 2019 Jan 30;10(1):511. doi: 10.1038/s41467-018-07983-4.
citation: Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.