| CTRI Number |
CTRI/2024/11/077460 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
People with shoulder problems after covid vaccine. |
|
Scientific Title of Study
|
Increase Incidence of Shoulder Capsular Pattern Restriction
Among Subjects Administrated with Covid Vaccination |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Sotra |
| Designation |
Post Graduate Student |
| Affiliation |
College Of Physiotherapy,Dayanand Sagar University |
| Address |
College Of Physiotherapy, Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura road Ramanagaradt. karnataka.
Banglore Rural
Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura road Ramanagaradt. karnataka.
Banglore Rural
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
7889665228 |
| Fax |
|
| Email |
mahimasotra45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima Sotra |
| Designation |
Post Graduate Student |
| Affiliation |
College Of Physiotherapy,Dayanand Sagar University |
| Address |
College of Physiotherapy, Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura Road Ramanagara Dt. karnataka.
Banglore Rural
Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura Road Ramanagara Dt. karnataka.
Banglore Rural
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
7889665228 |
| Fax |
|
| Email |
mahimasotra45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Kumar KC |
| Designation |
Professor |
| Affiliation |
College Of Physiotherapy, Dayanand Sagar University |
| Address |
Dayanand Sagar Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura Road Ramanagara Dt. karnataka.
Banglore Rural
Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura Road Ramanagara Dt. karnataka.
Banglore Rural
Bangalore
KARNATAKA
562112
India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinod-mpt@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Self
College Of Physiotherapy, Dayananda Sagar University, Devarakaggalahalli,Harohalli kanakapura Road Ramanagara Dt.
karanataka-562112 |
|
|
Primary Sponsor
|
| Name |
Mahima sotra |
| Address |
Dayanand Sagar University,Devarakaggalahalli,Harohalli,kanakapura Road Ramanagara Dt. karnataka.
Banglore Rural |
| 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 Mahima Sotra |
Dr. Chandramma Dayananda Sagar Institute of Medical Education & Research(CDSIMER) |
Devarakaggalahalli,Harohalli,Kanakapura Road
Ramanagara Dt.Karnataka-562112
Physiotherapy OPD
Room No.2
Bangalore Rural
KARNATAKA |
07889665228
mahimasotra45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayananda Sagar Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Restricted shoulder movement |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.subjects who are covid vaccinated.
2.male and female
3.age group:20-40 |
|
| ExclusionCriteria |
| Details |
1.history of fracture in upper limb.
2.diabetic patients.
3.cervical spondylosis
4.thoracic outlet syndrome.
5.rotator cuff tear. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Shoulder And Pain Disability Index
2.Goniometer |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
10/12/2024 |
| 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="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
|
The aim of the study is to assess and find out incidence of shoulder capsular pattern among subjects administrated with covid vaccination. Participants will be approched and explained about the study, screening will be done according to selection criteria. Participants fulfilling inclusion and exclusion criteria will be included. Data will be calculated and statistical analysis will be done to obtain results. |