The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going ChildrenNCT05314452
Reliability and Validity of 10 Meters Walk Test Among Children
An observational study of The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going Children, run by Asir John Samuel at 1 site in India.
Trial summary
Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going Children
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 12 Aug 2021to 15 Mar 2022
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Middle school going children from tertiary school of Mullana-Ambala region
Who may be able to join
- Asymptomatic middle school going children
- Boys and girls in the age group between 8 and 12 years
- Independent walking has achieved at age of 14 months
- Able to understand and follow commands of examiner.
Who cannot join
- Any Neurological disease
- Any musculoskeletal disease in Lower Limb
- Deformity in Lower Limb
- Past history of surgery in Lower Limb in past 1 year
- Any cardio-respiratory difficulties. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timed Motor Function Test Using Video Based Observation and Online Based Observation Among Middle School Going Children: A Reliability and Validity Study
Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Hence, the reliability and validity of video based observation and online based observation (VBO and OBO) methods to be explored. Middle school going children age group between 8 and 12 years was recruited for the study on the basis of convenience sampling. Sample size selected for each age group was according to sample size criteria of Interclass coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three methods; VBO, OBO and direct observation for three times to estimate intrarater reliability and three days within a week to estimate test-retest reliability. The mean of three readings was used to find the estimated value. Direct observation method was used as a criterion measure method to report concurrent validity. After concurrent validity, Test-retest Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity of VBO and OBO with direct observation was reported by recording 10 meters walk test in children.
- Keywords
- Child, Communication media, Health services, Reproducibility of results, Research design
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walk test (Direct observation method)
10 meters walk test (TMFTs) determined the walking abilities of an individual using mobile phone stopwatch.
Measured: Immediate after taking anthropometric measurements
10 meters walk test (Video based observation method)
10 meters walk test using video camera of mobile phone
Measured: Immediate after measuring 10 meters walk test with direct observation method
10 meters walk test (Online based observation method)
10 meters walk test using online mobile based application- WhatsApp
Measured: Immediate after measuring 10 meters walk test with Video based observation method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start12 Aug 2021
- Primary completion31 Jan 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going ChildrenStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Amit Kumar, (MPT), Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationAsir John Samuel, PhD, Study director, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314452
- Sponsor's protocol ID
- MMDU/IEC/2167
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timed Motor Function Test Using Video Based Observation and Online Based Observation Among Middle School Going Children: A Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT05314452
- Acronym / sponsor ID
- MMDU/IEC/2167
- Keywords
- Child, Communication media, Health services, Reproducibility of results, Research design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Hence, the reliability and validity of video based observation and online based observation (VBO and OBO) methods to be explored. Middle school going children age group between 8 and 12 years was recruited for the study on the basis of convenience sampling. Sample size selected for each age group was according to sample size criteria of Interclass coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three methods; VBO, OBO and direct observation for three times to estimate intrarater reliability and three days within a week to estimate test-retest reliability. The mean of three readings was used to find the estimated value. Direct observation method was used as a criterion measure method to report concurrent validity. After concurrent validity, Test-retest Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity of VBO and OBO with direct observation was reported by recording 10 meters walk test in children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Middle school going children from tertiary school of Mullana-Ambala region
Key inclusion criteria (4 listed)
- Asymptomatic middle school going children
- Boys and girls in the age group between 8 and 12 years
- Independent walking has achieved at age of 14 months
- Able to understand and follow commands of examiner.
Key exclusion criteria (5 listed)
- Any Neurological disease
- Any musculoskeletal disease in Lower Limb
- Deformity in Lower Limb
- Past history of surgery in Lower Limb in past 1 year
- Any cardio-respiratory difficulties. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
10 meters walk test (Direct observation method)
Time frame: Immediate after taking anthropometric measurements
10 meters walk test (TMFTs) determined the walking abilities of an individual using mobile phone stopwatch.
10 meters walk test (Video based observation method)
Time frame: Immediate after measuring 10 meters walk test with direct observation method
10 meters walk test using video camera of mobile phone
10 meters walk test (Online based observation method)
Time frame: Immediate after measuring 10 meters walk test with Video based observation method
10 meters walk test using online mobile based application- WhatsApp
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 6 Apr 2022.
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.
Amit Kumar, (MPT) principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Asir John Samuel, PhD study director
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
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 The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going Children, 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 5 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 6 Apr 2022. 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?
10 meters walk test (Direct observation method) (time frame: Immediate after taking anthropometric measurements). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.