| CTRI Number |
CTRI/2025/04/085262 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development and application of the stroke prediction model for bmtc bus drivers in banglore |
|
Scientific Title of Study
|
A study to find out risk of stroke in BMTC bus drivers using stroke prediction model in Bangalore |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prathibha S |
| Designation |
MPT (Neurological science) student |
| Affiliation |
Hosmat Hospital educational institute (Hosmat college of Physiotherapy) |
| Address |
Hosmat Hospital Educational instituteS
Deparment of Physiotherapy
Deparment of neurological sciences division ,2nd floor
Sy.No.5/2,HHEI campus,Preethi nagar,near Laggere Bridge,Banglore-58
Bangalore
KARNATAKA
560058
India |
| Phone |
8861126093 |
| Fax |
|
| Email |
pprathi1215@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnima Singh |
| Designation |
Principal of Hosmat College of Physiotherapy |
| Affiliation |
Hosmat Hospital educational institute (Hosmat college of Physiotherapy) |
| Address |
Hosmat Hospital Educational instituteS
Deparment of Physiotherapy
Deparment of neurological sciences division ,2nd floor
Sy.No.5/2,HHEI campus,Preethi nagar,near Laggere Bridge,Banglore-58
Bangalore
KARNATAKA
560058
India |
| Phone |
9886367792 |
| Fax |
|
| Email |
hheibng@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purnima Singh |
| Designation |
Principal of Hosmat College of Physiotherapy |
| Affiliation |
Hosmat Hospital educational institute (Hosmat college of Physiotherapy) |
| Address |
Hosmat Hospital Educational instituteS
Deparment of Physiotherapy
Deparment of neurological sciences division ,2nd floor
Sy.No.5/2,HHEI campus,Preethi nagar,near Laggere Bridge,Banglore-58
Bangalore
KARNATAKA
560058
India |
| Phone |
9886367792 |
| Fax |
|
| Email |
hheibng@gmail.com |
|
|
Source of Monetary or Material Support
|
| BMTC Depot no 9 (Peenya),26 (Yeshwanthpura) |
|
|
Primary Sponsor
|
| Name |
Prathibha S |
| Address |
Hosmat Hospital Educational instituteS
Deparment of Physiotherapy
Deparment of neurological sciences division ,2nd floor
Sy.No.5/2,HHEI campus,Preethi nagar,near Laggere Bridge,Banglore-58 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Renukaya |
Peenya BMTC bus depot |
Peenya BMTC bus depot No 9
peenya division
14 th cross Maruthi Nagar,Peenya Banglore 560058
Bangalore
KARNATAKA |
7760991409
renukaats@gmail.com |
| Gangadhar H |
Yeswanthpura BMTC bus depot |
BMTC DEPOT NO 26
Yeswanthpura division
ground floor
Bangalore
KARNATAKA |
7760991426
dm26@mybmtc.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Banglore metropolitan transport corporation |
Approved |
| Hosmat Hospital Educational Institutes |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
The participant should be a working BMTC bus driver,with atleast 10 years of working experiance |
|
| ExclusionCriteria |
| Details |
patients with brain stroke,end stage tumours and other neurological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroke Prediction Model |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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)
|
30/04/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a cross sectional study.The objective is to study the risk of stroke in BMTC bus drivers as driving a passenger bus is a sensitive and stressful job which has non standardized workings days,complex routes.theireffects results in drivers occupational diseases such as stroke.By investigating stroke risk factors,predicting the risk of stroke in bus drivers using stroke prediction model,we will be able to prevent the occurance of stroke by creating awareness and modifying risk factors with lifestyle interventions and early treatment. |