- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05159297
Normative Reference Values of Equilibrium Coordination Test Among Children
October 4, 2023 updated by: Asir John Samuel
Normative Reference Values of Sideways Walking, Tandem Walking, Cross-stepping, Heel Walking and Toe Walking Among Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1104
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
-
-
Haryana
-
Ambāla, Haryana, India, 133207
- Maharishi Markandeshwar International School
-
-
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
8 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Normal healthy children of age group between 8 and 17 years was recruited
Description
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 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: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sideways walking
Time Frame: Immediately after the sideways walking
|
This test will be used to find the normative values of sideways walking
|
Immediately after the sideways walking
|
|
Tandem walking
Time Frame: Immediately after the Tandem walking
|
This test will be used to find the normative values of tandem walking
|
Immediately after the Tandem walking
|
|
Cross stepping
Time Frame: Immediately after the Cross stepping
|
This test will be used to find the normative values of cross stepping
|
Immediately after the Cross stepping
|
|
Heel Walking
Time Frame: Immediately after the Heel Walking
|
This test will be used to find the normative values of heel walking
|
Immediately after the Heel Walking
|
|
Toe walking
Time Frame: Immediately after the Toe walking
|
This test will be used to find the normative values of toe walking
|
Immediately after the Toe walking
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nidhi Sharma, PhD Scholar, Maharishi Markendeshwar University (Deemed to be 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
November 2, 2021
Primary Completion (Actual)
August 19, 2023
Study Completion (Actual)
September 16, 2023
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
December 2, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMDU/IEC/2153
- U1111-1269-9876 (Other Identifier: Universal Trial Number (WHO))
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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