| CTRI Number |
CTRI/2025/07/090169 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How accurate and consistent the kannada version of TGMD 3 test is for checking movement skills in children from dakshina karnataka |
|
Scientific Title of Study
|
VALIDITY AND RELIABILITY OF TGMD-3 KANNADA VERSION (FUNDAMENTAL MOVEMENT SKILL) FOR CHILDREN IN DAKSHINA KANNADA |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi K |
| Designation |
Student |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8088324582 |
| Fax |
|
| Email |
lakshmikamalakar10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lakshmi K |
| Designation |
STUDENT |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
| Address |
ALVAS PHYSIOTHERAPY OPD ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE ALVAS HOSPITAL ROAD MOODUBIDIRE DAKSHINA KANNADA 574227 Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8088324582 |
| Fax |
|
| Email |
lakshmikamalakar10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Lakshmi K |
| Designation |
STUDENT |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
| Address |
ALVAS PHYSIOTHERAPY OPD ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE ALVAS HOSPITAL ROAD MOODUBIDIRE DAKSHINA KANNADA 574227
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8088324582 |
| Fax |
|
| Email |
lakshmikamalakar10@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNEMENT PRIMARY SCHOOL IN MOODBIDRI |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshmi K |
ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri 574227
Dakshina Kannada KARNATAKA |
8088324582
lakshmikamalakar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TGMD 3 SCALE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Both boys and girls
Within the age range of 8 to 12 years
According to World health organisation the Body mass index should be 5 to less than 85 percent
Participants who understand the guidelines in kannada and who speaks kannada
Students Gaurdian Parenets who willing for consent |
|
| ExclusionCriteria |
| Details |
Children with physical visual and hearing disabilities
Sensory impaired children
Recent injuries Recent surgeries Bed ridden and Immobilized children
Systemic or comorbid illness
Congenital health issues
Cognitive or intellectual challenge
Students Parents or Gaurdian not willing for the consent
Hypermobile and Hypomobile children
Children who dont understand kannada |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Test of Gross Motor Devolopment version 3 in english version |
45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Movement Assessment Battery for Children-2 |
40 minutes |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the validity and reliability of the Kannada translated version of the Test of Gross Motor Development -Third edition (TGMD-3) for assessing fundamental movement skills among children in Dakshina Kannada, Karnataka. TGMD-3 is a widely accepted, standardized tool used globally to assess gross motor development in children 3 to 12 years. However, there is a lack of validated versions for Kannada-speaking populations, which can lead to potential cultural and linguistic misinterpretation. The study employs an observational design and includes 64 children aged 8-12 years selected through non-probability convenience sampling. The research involves the translation and cultural adaptation of TGMD-3 into Kannada, followed by an assessment of its content and concurrent validity (using MABC as a comparison) as well as test-retest and inter-rater reliability. The study is divided into phases: initial linguistic validation , expert evaluation for content validity, testing for concurrent validity, and separate reliability testing. Data will be collected from school children in Moodbidri, and statistical analysis will include correlation coefficients, Cronbach’s alpha, and other relevant measures. This research is significant as it will provide a culturally relevant, reliable, and valid motor skill assessment tool for Kannada-speaking children. The findings are expected to enhance early identification of motor delays and inform interventions in both educational and clinical settings, supporting child development policies and programs in Karnataka. Early identification of motor development delays is essential for ensuring timely interventions that can positively influence a child’s physical, cognitive and social development. However, assessment tools ,like TGMD-3, originally developed in English, may not accurately reflect the abilities of children from non-English-speaking backgrounds without proper cultural adaptation. By validating a Kannada version of TGMD-3, the study addresses a critical gap in regional child health assessment. The culturally adapted tool will enable educators, clinicians, and researchers to conduct accurate evaluations, promote inclusive education, and design appropriate physical activity programs. This initiative aligns with national ang global health strategies aimed at improving child development outcomes through standardized and accessible assessment methods. |