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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05159297
Other study ID # MMDU/IEC/2153
Secondary ID U1111-1269-9876
Status Completed
Phase
First received
Last updated
Start date November 2, 2021
Est. completion date September 16, 2023

Study information

Verified date October 2023
Source Maharishi Markendeswar University (Deemed to be University)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

756 children will be recruited of age group 8-15 years. Five equilibrium coordination tests i.e. Sideways walking, tandem walking, cross-stepping, heel walking and toe walking will be performed by each child and three readings will be recorded. Mean of three readings will be considered as normative reference value of each test respectively.


Recruitment information / eligibility

Status Completed
Enrollment 1104
Est. completion date September 16, 2023
Est. primary completion date August 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reference values
Normative reference values of coordination tests will be obtained

Locations

Country Name City State
India Maharishi Markandeshwar International School Ambala Haryana

Sponsors (2)

Lead Sponsor Collaborator
Asir John Samuel Maharishi Markandeshwar International School, Mullana

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sideways walking This test will be used to find the normative values of sideways walking Immediately after the sideways walking
Primary Tandem walking This test will be used to find the normative values of tandem walking Immediately after the Tandem walking
Primary Cross stepping This test will be used to find the normative values of cross stepping Immediately after the Cross stepping
Primary Heel Walking This test will be used to find the normative values of heel walking Immediately after the Heel Walking
Primary Toe walking This test will be used to find the normative values of toe walking Immediately after the Toe walking
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