- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649436
Assessment of Developmental Status and Locomotor Balance in Healthy Children.
March 31, 2023 updated by: Riphah International University
Assessment of Developmental Status and Locomotor Balance in Healthy Children. A Normative Study.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Govt College of Technology for women, Day care center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 5 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
daycare centers primary schools
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ages and Stages Questionnaire
Time Frame: last one week
|
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
Time Frame: last one week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: shabana ashraf, Phd, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2022
Primary Completion (Actual)
February 15, 2023
Study Completion (Actual)
February 15, 2023
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 31, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/22/00736 Duaa Ijaz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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