| CTRI Number |
CTRI/2024/06/069196 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of outreach clinics in villages on reducing the burden of caregivers of Children with disability |
|
Scientific Title of Study
|
Impact of a Model Physiotherapy Centre on the Quality of Life of Disabled Children from UBA Adopted Villages by Reducing Caregiver Burden: Developing a Model |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No:PT-16, SRM College of Physiotherapy, SRM Instituute of Science and
Technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No: PT-16, SRM College of Physiotherapy, SRM Instituute of Science and
Technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No: PT-16, SRM College of Physiotherapy, SRM Instituute of Science and
Technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Institute of Science and technology, Kattankulathur,
Chengalpattu. |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
Kattankulathur, Chengalpattu, Tamil Nadu - 60302, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vadivelan K |
UBA-SRMIST adopted Villages |
Kolathur, Chettipuniyam, Orathur, Nattarsanpattu, Anjur, Thenmelpakkam, Pattaravakkam, Kalivanthapattu, Baburayanpettai, Minnal Chithamur, Kilathivakkam and Chunambedu.
Kancheepuram
TAMIL NADU |
9841298555
vadivelk@srmist.edu.in |
| Veeragoudhaman T S |
UBA-SRMIST adopted Villages |
Kolathur, Chettipuniyam, Orathur, Nattarsanpattu, Anjur, Thenmelpakkam, Pattaravakkam, Kalivanthapattu, Baburayanpettai, Minnal Chithamur, Kilathivakkam and Chunambedu.
Kancheepuram
TAMIL NADU |
9500375408
dean.pt.ktr@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z753||Unavailability and inaccessibilityof health-care facilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Neurodevelopmental Interventions |
Screening for neurodevelopmental disorders
Incorporating tailored rehabilitation protocols for every individual
Techniques like sensory integration, neurodevelopmental therapy and motor learning will be included |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age of 3 - 5 years diagnosed to have any form neurodevelopmental disorder or disability will be included |
|
| ExclusionCriteria |
| Details |
Parents with children of disability temporarily migrated and parents who are not ready to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced caregiver burden |
Baseline and endline assessments of caregiver burden will be taken prior to the commencement of rehabilitation and after one year of rehabilitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced disability levels of children |
Baseline and endline assessments of disability levels will be taken prior to the commencement of rehabilitation and after one year of rehabilitation |
| Data registry for the prevalence of disabilities, developmental abnormalities, and risk factors among preschool children registered in anganwadi in the selected villages |
One time cross-sectional study.
This is will be assessed in the initial phase of study where the entire population of preschool aged anganwadi children will be screened for neurodevelopmental disorders and disability |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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="2"
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
|
The study will commence with screening all preschool
children registered in Anganwadi in the designated villages. Tailored model
clinics will be set up in these villages based on the prevalence of NDD. Once
established, children diagnosed with NDD will undergo rehabilitation for a
year. Baseline and endline assessments will be conducted to evaluate the
effectiveness of the model center on both the child’s disability and the
caregiver burden. |