NCT05649436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

December 6, 2022

Last Update Submit

March 31, 2023

Conditions

Development, Child

Keywords

balancedevelopmental milestonelocomotor balanceproprioceptionages and stages questionnairetimed up and go test

Outcome Measures

Primary Outcomes (2)

  • Ages and Stages Questionnaire

    It is parent-completed questionnaires for young children. It ranges from age 1 to 60 months and consists of 19 different questionnaires.The questionnaires cover over five different domains: communication, gross motor, fine motor, problem solving and personal social skills.If the child scores below cut off value he needs further medical assessment otherwise he is healthy. Cut off values are different for each domain.

    last one week

  • Timed Up and Go test

    Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 2 On the word "Go," begin timing. 3 Stop timing after patient sits back down. 4 Record time. Observe the patient's postural stability, gait, stride length, and sway.

    last one week

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

daycare centers primary schools

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Govt College of Technology for women, Day care center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Fauls JR, Thompson BL, Johnston LM. Validity of the Ages and Stages Questionnaire to identify young children with gross motor difficulties who require physiotherapy assessment. Dev Med Child Neurol. 2020 Jul;62(7):837-844. doi: 10.1111/dmcn.14480. Epub 2020 Feb 11.

    PMID: 32043571BACKGROUND

  • 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.

    PMID: 27882544BACKGROUND

  • 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.

    PMID: 24648635BACKGROUND

  • 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.

    PMID: 27661232BACKGROUND

  • 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.

    PMID: 30700709BACKGROUND

  • 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.

    PMID: 30828632BACKGROUND

Study Officials

  • shabana ashraf, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

January 15, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)