Development, ChildNCT05649436
Assessment of Developmental Status and Locomotor Balance in Healthy Children.
An observational study of Development, Child, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Development, Child
- How many people
- 500 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- Child
Study population: daycare centers primary schools
Who may be able to join
- 2 months to 5 years of age
- Families living in urban areas
- Families with financial stability when the child was growing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Govt College of Technology for women, Day care center
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Conditions
- Development, Child
- Keywords
- balance, developmental milestone, locomotor balance, proprioception, ages and stages questionnaire, timed up and go test
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: last one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Jan 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shabana ashraf, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649436
- Sponsor's protocol ID
- REC/22/00736 Duaa Ijaz
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32043571Agarwal 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.
PubMed 27882544Park 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.
PubMed 24648635Verbecque 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.
PubMed 27661232Villar 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.
PubMed 30700709Osoba 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.
PubMed 30828632
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Developmental Status and Locomotor Balance in Healthy Children. A Normative Study.
- ClinicalTrials.gov ID
- NCT05649436
- Acronym / sponsor ID
- REC/22/00736 Duaa Ijaz
- Conditions
- Development, Child
- Keywords
- balance, developmental milestone, locomotor balance, proprioception, ages and stages questionnaire, timed up and go test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- daycare centers primary schools
Key inclusion criteria (3 listed)
- 2 months to 5 years of age
- Families living in urban areas
- Families with financial stability when the child was growing
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 32043571Fauls 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.
- Background: PubMed 27882544Agarwal 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.
- Background: PubMed 24648635Park 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.
- Background: PubMed 27661232Verbecque 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.
- Background: PubMed 30700709Villar 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.
- Background: PubMed 30828632Osoba 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.
- Individual participant dataSharing planned: No
Related trials for Development, Child
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shabana ashraf, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Child, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ages and Stages Questionnaire (time frame: last one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649436, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.