Coordination Disorder, DevelopmentalNCT05159297
Normative Reference Values of Equilibrium Coordination Test Among Children
An observational study of Coordination Disorder, Developmental, run by Asir John Samuel at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Coordination Disorder, Developmental
- What is being tested?
- Reference values
- How many people
- 1,104 participants
- Where
- 1 siteIndia
- Study dates
- 2 Nov 2021to 16 Sep 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Normal healthy children of age group between 8 and 17 years was recruited
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Maharishi Markandeshwar International School
Ambāla, Haryana, 133207
About this study
Official title: 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.
Read the 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.
- Conditions
- Coordination Disorder, Developmental
- Being tested
- Reference values
- Keywords
- children, coordination, normal range, postural balance, walking
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference valuesOther
Normative reference values of coordination tests will be obtained
What is being measured
The primary outcome is the main question the study is designed to answer.
Sideways walking
This test will be used to find the normative values of sideways walking
Measured: Immediately after the sideways walking
Tandem walking
This test will be used to find the normative values of tandem walking
Measured: Immediately after the Tandem walking
Cross stepping
This test will be used to find the normative values of cross stepping
Measured: Immediately after the Cross stepping
Heel Walking
This test will be used to find the normative values of heel walking
Measured: Immediately after the Heel Walking
Toe walking
This test will be used to find the normative values of toe walking
Measured: Immediately after the Toe walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start2 Nov 2021
- Primary completion19 Aug 2023
- Study completion16 Sep 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 Coordination Disorder, DevelopmentalStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markandeshwar International School, Mullana
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Nidhi Sharma, PhD Scholar, Principal investigator, Maharishi Markendeshwar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159297
- Sponsor's protocol ID
- MMDU/IEC/2153
- Other IDs
- U1111-1269-9876
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32173035Riquelme 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.
PubMed 30024779McKay 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.
PubMed 27881628Bolk 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.
PubMed 29868837Dunsky 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.
PubMed 31803048Lanzino 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.
PubMed 22850331
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Reference Values of Sideways Walking, Tandem Walking, Cross-stepping, Heel Walking and Toe Walking Among Children
- ClinicalTrials.gov ID
- NCT05159297
- Acronym / sponsor ID
- MMDU/IEC/2153
- Conditions
- Coordination Disorder, Developmental
- Keywords
- children, coordination, normal range, postural balance, walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markandeshwar International School, Mullana
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 16 Dec 2021 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Normal healthy children of age group between 8 and 17 years was recruited
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference valuesNormative reference values of coordination tests will be obtained | Other | – |
Primary outcome
Sideways walking
Time frame: Immediately after the sideways walking
This test will be used to find the normative values of sideways walking
Tandem walking
Time frame: Immediately after the Tandem walking
This test will be used to find the normative values of tandem walking
Cross stepping
Time frame: Immediately after the Cross stepping
This test will be used to find the normative values of cross stepping
Heel Walking
Time frame: Immediately after the Heel Walking
This test will be used to find the normative values of heel walking
Toe walking
Time frame: Immediately after the Toe walking
This test will be used to find the normative values of toe walking
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 5 Oct 2023.
- Background: PubMed 32173035Aylar 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.
- Background: PubMed 30024779Riquelme 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.
- Background: PubMed 27881628McKay 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.
- Background: PubMed 29868837Bolk 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.
- Background: PubMed 31803048Dunsky 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.
- Background: PubMed 22850331Lanzino 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.
- Individual participant dataSharing planned: No
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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.
Nidhi Sharma, PhD Scholar principal investigator
Maharishi Markendeshwar University (Deemed to be 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 Coordination Disorder, Developmental, run by Asir John Samuel at 1 site in India.
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 4 inclusion and 6 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 5 Oct 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 India. 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?
Sideways walking (time frame: Immediately after the sideways walking). The study lists 5 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 NCT05159297, 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 5 Oct 2023.