Clinical trial NCT05159297: Normative Reference Values of Equilibrium Coordination Test Among Children
Official title: Normative Reference Values of Sideways Walking, Tandem Walking, Cross-stepping, Heel Walking and Toe Walking Among Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coordination Disorder, Developmental
Keywords: children
coordination
normal range
postural balance
walking
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Maharishi Markandeshwar International School, Mullana
First posted: 2021-12-16
Enrollment: 1104
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Normal healthy children of age group between 8 and 17 years was recruited

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sideways walking
timeFrame: Immediately after the sideways walking
measure: Tandem walking
timeFrame: Immediately after the Tandem walking
measure: Cross stepping
timeFrame: Immediately after the Cross stepping
measure: Heel Walking
timeFrame: Immediately after the Heel Walking
measure: Toe walking
timeFrame: Immediately after the Toe walking
Secondary outcomes:
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Maharishi Markandeshwar International School
state: Haryana
Study officials:
affiliation: Maharishi Markendeshwar University (Deemed to be University)
name: Nidhi Sharma, PhD Scholar
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.