| CTRI Number |
CTRI/2024/03/063754 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Functional Outcome and Quality of Life in different types of Stroke at three months of occurrence |
|
Scientific Title of Study
|
Functional Outcome and Quality of Life in Hemorrhagic and Ischemic Stroke at three months of occurrence |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
John lance kulzner L |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
faculty of physiotherapy
2nd floor
1- sri ramachandra nagar porur chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
6381238346 |
| Fax |
|
| Email |
johnlancekulzner@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs M Rajeswari |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
faculty of physiotherapy
1st floor
1- sri ramachandra nagar porur chennai 116
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs M Rajeswari |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
faculty of physiotherapy
1st floor
1- sri ramachandra nagar porur chennai 116
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research
facutly of physiotherapy,
2nd floor
1-sriramachandra nagar 600116 |
|
|
Primary Sponsor
|
| Name |
John Lance Kulzner L |
| Address |
1-Sri Ramachandra nagar
Porur Chennai 116 |
| 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 |
| John Lance Kulzner L |
Sri Ramachandra Medical Centre |
Faculty of Physiotherapy 2nd floor
1- Sri Ramachandra nagar Porur Chennai 116
Chennai
TAMIL NADU |
6381238346
johnlancekulzner@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Three months post stroke survivors
first time stroke survivors
|
|
| ExclusionCriteria |
| Details |
associated long term cognitive and perceptual disorders
recurrent stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life and Functional Independent |
12 Weeks After Stroke |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rand 36 and Barthel index |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
12/03/2024 |
| 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="5"
Days="0" |
|
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
|
The details of post stroke patient who were admitted in Ramachandra hospital before three months will be obtained from the medical record department and the patients who return back for review at three months of follow up will also be taken. patients will be included based on the inclusion and exclusion criteria and informed consent obtained from the study population the basic information will be obtained from the records and through telephonic conversation from the patients. The quality of life and functional outcome will be obtained from the patients the interview will be proceeded by asking questions based on rand 36 and Barthel index scales. |