NCT05314452

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

ChildCommunication mediaHealth servicesReproducibility of resultsResearch design

Outcome Measures

Primary Outcomes (3)

  • 10 meters walk test (Direct observation method)

    10 meters walk test (TMFTs) determined the walking abilities of an individual using mobile phone stopwatch.

    Immediate after taking anthropometric measurements

  • 10 meters walk test (Video based observation method)

    10 meters walk test using video camera of mobile phone

    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

    Immediate after measuring 10 meters walk test with Video based observation method

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Middle school going children from tertiary school of Mullana-Ambala region

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar International school

Ambāla, Ambala, 133207, India

Location

Study Officials

  • Amit Kumar, (MPT)

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Asir John Samuel, PhD

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 6, 2022

Study Start

August 12, 2021

Primary Completion

January 31, 2022

Study Completion

March 15, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations