NCT05159297

Brief Summary

A cross-sectional study will be conducted recruiting children of age group 8-15 years. Pilot study has been conducted for the determination of the sample size. The calculated sample size has come out to be, n=378 which can be taken for males and females separately. Stratified random sampling will be done according to age. Child will be asked to perform all tests one by one and the time taken (in seconds) will be noted required to perform the tests. The mean of three readings will be obtained using a mobile-based stop watch.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,104

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

October 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

October 1, 2021

Last Update Submit

October 4, 2023

Conditions

Keywords

childrencoordinationnormal rangepostural balancewalking

Outcome Measures

Primary Outcomes (5)

  • Sideways walking

    This test will be used to find the normative values of sideways walking

    Immediately after the sideways walking

  • Tandem walking

    This test will be used to find the normative values of tandem walking

    Immediately after the Tandem walking

  • Cross stepping

    This test will be used to find the normative values of cross stepping

    Immediately after the Cross stepping

  • Heel Walking

    This test will be used to find the normative values of heel walking

    Immediately after the Heel Walking

  • Toe walking

    This test will be used to find the normative values of toe walking

    Immediately after the Toe walking

Interventions

Normative reference values of coordination tests will be obtained

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Normal healthy children of age group between 8 and 17 years was recruited

You may qualify if:

  • Typically developing school-going children with age group between 8 and 15 years
  • Both male and female
  • Able to walk independently
  • Able to follow verbal commands

You may not qualify if:

  • Any fracture of lower limb in last 6 months
  • Any congenital anomaly affecting lower limb
  • Any developmental disorder
  • Any open wounds
  • Those who are using any kind of assistive devices
  • Any condition that affect the health status of the participants during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar International School

Ambāla, Haryana, 133207, India

Location

Related Publications (6)

  • Aylar MF, Dionisio VC, Jafarnezhadgero A, Parikhani AZ. Body coordination during sit-to-stand in blind and sighted female children. J Biomech. 2020 May 7;104:109708. doi: 10.1016/j.jbiomech.2020.109708. Epub 2020 Feb 28.

    PMID: 32173035BACKGROUND
  • Riquelme I, Arnould C, Hatem SM, Bleyenheuft Y. The Two-Arm Coordination Test: Maturation of Bimanual Coordination in Typically Developing Children and Deficits in Children with Unilateral Cerebral Palsy. Dev Neurorehabil. 2019 Jul;22(5):312-320. doi: 10.1080/17518423.2018.1498552. Epub 2018 Jul 19.

    PMID: 30024779BACKGROUND
  • McKay MJ, Baldwin JN, Ferreira P, Simic M, Vanicek N, Burns J; 1000 Norms Project Consortium. Normative reference values for strength and flexibility of 1,000 children and adults. Neurology. 2017 Jan 3;88(1):36-43. doi: 10.1212/WNL.0000000000003466. Epub 2016 Nov 23.

    PMID: 27881628BACKGROUND
  • Bolk J, Farooqi A, Hafstrom M, Aden U, Serenius F. Developmental Coordination Disorder and Its Association With Developmental Comorbidities at 6.5 Years in Apparently Healthy Children Born Extremely Preterm. JAMA Pediatr. 2018 Aug 1;172(8):765-774. doi: 10.1001/jamapediatrics.2018.1394.

    PMID: 29868837BACKGROUND
  • Dunsky A. The Effect of Balance and Coordination Exercises on Quality of Life in Older Adults: A Mini-Review. Front Aging Neurosci. 2019 Nov 15;11:318. doi: 10.3389/fnagi.2019.00318. eCollection 2019.

    PMID: 31803048BACKGROUND
  • Lanzino DJ, Rabinstein A, Kinlaw D, Hepburn SB, Ness BM, Olson KJ, Sobie SM, Hollman JH. Coordination tests in persons with acute central nervous system pathology: assessment of interrater reliability and known-group validity. J Neurol Phys Ther. 2012 Sep;36(3):122-30. doi: 10.1097/NPT.0b013e3182641d36.

    PMID: 22850331BACKGROUND

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Reference Values

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Study Officials

  • Nidhi Sharma, PhD Scholar

    Maharishi Markendeshwar University (Deemed to be University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

December 16, 2021

Study Start

November 2, 2021

Primary Completion

August 19, 2023

Study Completion

September 16, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations