| CTRI Number |
CTRI/2024/03/064271 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Percentage of children with cerebral palsy having hip displacement by Xray and examination. |
|
Scientific Title of Study
|
Prevalence of Hip Displacement in children with Cerebral Palsy in Belagavi Taluka: A Clinico-radiological evaluation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Metgud |
| Designation |
MPT PhD |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center department of pediatric physiotherapy room no 39 sagar floor Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
MPT PhD |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center department of pediatric physiotherapy room no 39 sagar floor Belagavi
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bavi Shreya Mallikarjun |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center department of pediatric physiotherapy room no 39 sagar floor Belagavi
Advanced Physiotherapy center department of pediatric physiotherapy room no 39 sagar floor Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7420876067 |
| Fax |
- |
| Email |
shreya682000@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Metgud |
KAHER Institute of Physiotherapy |
Advanced Physiotherapy center department of pediatric physiotherapy room no 39 sagar floor Belagavi
Belgaum
KARNATAKA |
9845861236
drdeepa_metgud@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KAHER institute of physiotherapy |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Cerebral Palsy (all types) and locomotor disabilities which are registered in the district disability office
2. Both male and female children in the age group of 2-18 years
3. Parents who are willing to visit tertiary care hospital, Belagavi for the radiographic examination of their child |
|
| ExclusionCriteria |
| Details |
1. Children diagnosed with developmental disabilities other than cerebral palsy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Migration percentage |
T0 at the time of baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gross Motor Function Classification System Expanded Revised |
T0 at the time of baseline |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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)
|
28/03/2024 |
| 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="0"
Months="6"
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
|
Hip displacement is a risk factor for all children with cerebral palsy (CP) but is preventable in many cases. Cerebral palsy children visiting the Paediatric Neurology OPD and those registered in the District Disability Office will be recruited based on the inclusion and exclusion criteria. Informed consent will be taken from their parents following which clinical examination will be done. Then, an anteroposterior (AP) radiograph of the pelvis with both hips will be taken in a standardized manner. Migration percentage will be calculated to estimate the amount of displacement |