Assessment of Developmental Status and Locomotor Balance in Healthy Children.

Development, Child Clinical Trial

Official title:

Assessment of Developmental Status and Locomotor Balance in Healthy Children. A Normative Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649436
• Other study ID #: REC/22/00736 Duaa Ijaz
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Development, Child

Locations

Country	Name	City	State
Pakistan	Govt College of Technology for women, Day care center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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