| CTRI Number |
CTRI/2024/07/071586 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
physical strains on parents of kids with developmental issues |
|
Scientific Title of Study
|
Musculoskeletal disorders amongst primary caregivers of Children with neurodevelopmental disorders |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mutturaj Ranjanagi |
| Designation |
postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13 CBR Physiotherapy department SDM College of Medical sciences and Hospital Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8880561349 |
| Fax |
|
| Email |
mutturajranjanagi37079@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mutturaj Ranjanagi |
| Designation |
postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13 CBR Physiotherapy department SDM College of Medical sciences and Hospital Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8880561349 |
| Fax |
|
| Email |
mutturajranjanagi37079@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Appannavar |
| Designation |
Associate Professor and PG guide |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13 CBR Physiotherapy department SDM College of Medical sciences and Hospital Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9591753487 |
| Fax |
|
| Email |
sangeeta.appannavar@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital Manjushree Nagar Sattur Dharwad 580009
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Mutturaj Ranjanagi |
| Address |
SDM college of medical sciences and Hospital Manjushree nagar Sattur Dharwad Karnataka 580009 |
| 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 |
| Mutturaj Ranjanagi |
SDM Hospital Dharwad |
OPD number 13
CBR physiotherapy department SDM medical hospital
Manjushree Nagar Sattur Dharwad
KARNATAKA
Dharwad
KARNATAKA |
8880561349
mutturajranjanagi37079@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Primary care-givers of children with NDD (age 3-15 years)
Primary care-givers age 18-60years.
Primary care givers should be associated and taking care of the child with NDD for at least 1year or more.
Primary care givers can be either parents, aunty, uncle, nanny, or any other relative of the child.
Child with NDD should be diagnosed primarily by the Pediatrician |
|
| ExclusionCriteria |
| Details |
Primary care-givers of children with NDD who are pre diagnosed with musculoskeletal issues like Rheumatoid arthritis, Cancer or any other co-morbid status.
Primary care-givers who are not willing to participate in the study.
Primary care-givers who are on any kind of medications like (Anti-psychotic drugs etc.) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nordic musculoskeletal questionnaire scale |
Nordic musculoskeletal questionnaire is given to the primary caregivers to tick yes or no this will be assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Care giver strain index scale |
Care giver strain index this scale is given to primary caregivers to tick yes or no in respective components this scale will be assessed at baseline |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/08/2024 |
| 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="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
|
Data will be collected in camps held across rural and urban areas of Hubli-Dharwad, special schools, Pediatric Physiotherapy OPD @ SDMCMS&H. Primary care givers of children with NDD across rural and urban areas of Hubli-Dharwad, special schools and Pediatric Physiotherapy OPD @ SDMCMS&H.Sample size calculated using N = 4pq/d2 Where, N is the required sample size p stands for prevalence q is 100-p d is allowable error (5-20% of p) according to this formula required sample size will be 62.
Primary Care givers of children with NDD will be included according to the inclusion criteria. As a evaluation procedure each child with NDD would have undergone GMFCS and the same will be noted. The primary care-givers will be explained about the need and objective of the study. Informed consent will be taken. Primary care givers will be assessed based on demographic data and self-administered questionnaires like Nordic Musculoskeletal Questinnaire and Caregiver Strain Index. These questionnaires illustrate the amount of musculoskeletal disorder and distress respectively that is felt by the care givers. Questionnaires may take maximum 15-20 minutes by each individual.
|