| CTRI Number |
CTRI/2025/08/093123 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A community survey to find how common disabilities are, their types, and related factors in Devarayasamudra village, Karnataka. |
|
Scientific Title of Study
|
PREVALENCE , PATTERN AND DETERMINANTS OF DISABILITIES IN DEVARAYASAMUDRA – A CROSS SECTIONAL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashna Ravi |
| Designation |
Master of Physiotherapy |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka |
| Address |
RL Jalappa College Of Physiotherapy, Department of Physiotherapy
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
8301018910 |
| Fax |
|
| Email |
ashnaravi6713@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumar E |
| Designation |
Professor |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka |
| Address |
RL Jalappa College Of Physiotherapy ,Department of Physiotherapy
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
senthilkumar@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil Kumar E |
| Designation |
Professor |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka |
| Address |
RL Jalappa College Of Physiotherapy ,Department of Physiotherapy
Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar,Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
senthilkumar@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj URS Academy of Higher Education and Research, Tamaka,Kolar, Karnataka 563103 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj URS Academy of Higher Education and Research, |
| Address |
Sri Devaraj URS Academy of Higher Education and Research,Tamaka, Kolar,Karnataka 563103 |
| Type of Sponsor |
Other [Deemed to be university] |
|
|
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 |
| Ashna Ravi |
Devarayasamudra |
Rural Health Training Center Devarayasamudra Mulbagal,Kolar, Karnataka Department of Community Medicine 563127( Sri Devaraj URS Medical College )
Kolar
KARNATAKA |
08301018910
ashnaravi6713@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj URS Academy Education and Research Tamaka,Kolar,Karnataka 563103 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Permanent residents of Devarayasamudra village (Phase 1 & Phase 2) who are available during the survey period.
2.Individuals of all age groups and both sexes (pediatric, adult, and geriatric categories).
3.Participants willing to provide informed consent (for minors, assent will be obtained along with parental/guardian consent).
4.Individuals with or without disability for the purpose of estimating prevalence and pattern.
|
|
| ExclusionCriteria |
| Details |
1.Individuals not residing in Devarayasamudra at the time of data collection (e.g., temporary visitors).
2.Individuals unwilling or unable to provide informed consent (or assent in the case of minors).
3.Severely ill or medically unstable individuals where participation may pose a health risk.
4.Persons with temporary impairments (e.g., acute injuries expected to recover within 3 months) that do not qualify as disabilities per WHO–ICF classification.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Disabilities in the population of Devarayasamudra village, assessed through a door-to-door community-based survey using a structured and validated questionnaire.
Measurement:
Proportion (%) of individuals with any form of disability (e.g., locomotor, visual, hearing, speech, mental, or multiple), calculated from total surveyed population. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="236"
Sample Size from India="236"
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)
|
01/09/2025 |
| 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="1"
Months="0"
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 is a cross sectional, community based observational study conducted to determine the prevalence, pattern and determinants of disabilities in Devarayasamudra village, Kolar District, Karnataka. The study includes all residents of the village who are willing to participate and provide informed consent. The first phase involves door to door surveys using a structured and validated questionnaire to collect data on demographic details, type of disability, cause, and environmental factors. The second phase includes clinical assessment of individuals with locomotor disabilities using guidelines issued by the Ministry of Social Justice and Empowerment. The study aims to identify the proportion of individuals with disabilities, types of disabilities, and associated factors. The results will help in understanding the needs of the community and assist in planning rehabilitation and support services for individuals with disabilities. |