| CTRI Number |
CTRI/2025/01/079707 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Creating and validating a community based assessment tool for evaluating children with disabilities |
|
Scientific Title of Study
|
Development and Validation of an Assessment tool for evaluation of Children with disabilities in the Community |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ancilla Blessy Verghese |
| Designation |
BPT Intern |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
-
Udupi
KARNATAKA
576104
India |
| Phone |
8105099202 |
| Fax |
- |
| Email |
ancilla.verghese@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sidhiprada Mohapatra |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
-
Udupi
KARNATAKA
576104
India |
| Phone |
8050730675 |
| Fax |
- |
| Email |
sidhi.mohapatra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sidhiprada Mohapatra |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
-
Udupi
KARNATAKA
576104
India |
| Phone |
8050730675 |
| Fax |
- |
| Email |
sidhi.mohapatra@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Amar Seva Sangam, 6-2-47, Sivan Kovil St, Ayikudy -627852, Tamil Nadu |
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Sidhiprada Mohapatra |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 Franzina Coutinho |
Amar Seva Sangam |
Sulochana Gardens, Tenkasi Road, Ayikudy, PIN code 627852, Tenkasi District, Tamil Nadu, India.
Thiruvarur
TAMIL NADU |
9769191318
-
franzina.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
For Content Validation:
Experts with at least 1 year of experience in treating children with disabilities. Availability to commit time to assess the assessment form.
For Concurrent validation and Reliability:
Children with locomotor and neurodivergent disabilities that include- Cerebral palsy, Muscular dystrophy, Spina bifida, Down syndrome, Attention-deficit/hyperactivity disorder, Specific learning disabilities, Intellectual disability
|
|
| ExclusionCriteria |
| Details |
Children with mental illness, Children without disabilities, Children above the age of 15 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For content validation:
Content Validation Index (CVI) (which is set at 0.80)
For Inter-rater Reliability of the assessment tool:
Intra-class correlation coefficient (ICC) values among the investigators administering the tool.
|
Content Validation: Baseline
Inter-rater reliability: Rater centric timepoints
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of items retained after expert review & Likert scale scoring (80%)
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/02/2025 |
| 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="3"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 create and validate an assessment tool specifically designed for children with disabilities (CWD) in community settings. The tool will cover important areas such as body structure and function, activity limitations, participation restrictions, and contextual factors, based on the International Classification of Functioning, Disability, and Health for Children and Youth (ICF-CY). The research will be conducted in three stages: developing the tool, refining it with input from experts, and testing its reliability and validity by comparing it with an established gold-standard tool. The study will involve children with disabilities (aged 0-15 years, focusing on locomotor and neurodivergent conditions) and experts in the field. The outcomes are anticipated to enhance long-term intervention planning for children with disabilities, benefiting both individuals and society. |