| CTRI Number |
CTRI/2025/01/079810 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Joint Issues and Pain in Kathak Dancers |
|
Scientific Title of Study
|
Prevalence of Joint Hyper-mobility and its Association with Pain in Kathak Dancers |
| 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 Anshu Sharma |
| Designation |
Masters of physiotherapy student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok, East Sikkim
East SIKKIM 737102 India |
| Phone |
8250729104 |
| Fax |
|
| Email |
anshusharmagtk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajoy Daniel Rai |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok, East Sikkim
East SIKKIM 737102 India |
| Phone |
9593372169 |
| Fax |
|
| Email |
ajoydaniel.r@smims.smu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Anshu Sharma |
| Designation |
Masters of physiotherapy student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok, East Sikkim
East SIKKIM 737102 India |
| Phone |
8250729104 |
| Fax |
|
| Email |
anshusharmagtk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital, 5th Mile Tadong, Gangtok, East Sikkim, India, 737102 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL ] |
|
|
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 Anshu Sharma |
Central Referral Hospital |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok, East Sikkim East SIKKIM |
8250729104
anshusharmagtk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Dancers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Kathak Dancers registered among dance classes of Sikkim and Siliguri, Age 18-60 years, Both genders, Having a Dance experience for 1 year and above |
|
| ExclusionCriteria |
| Details |
Unwilling to participate in the study, individual who has a history of joint hyper mobility syndrome, or other musculoskeletal disorders, individual with a recent joint injuries, and pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Beighton score and Goniometer
2. Visual Analogue Scale |
At the time of assessment (single point during participant evaluation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participant specific functional scale |
At the time of assessment (single point during participant evaluation) |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
16/02/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
In my upcoming study, I will be recruiting dancers (Kathak dancers) based on specific inclusion and exclusion criteria. After recruitment, I will provide the participants with a participation information sheet, followed by obtaining their consent. They will then complete a demographic data sheet regarding their frequency and intensity of practice. The first outcome measure will be the Beighton Score which will assess the hypermobility, followed by pain assessment using the Visual Analog Scale (VAS) by asking participants to mark their pain on a body chart. Finally, participants will complete a Participant-Specific Functional Scale, evaluating their difficulty in performing seven Kathak-specific dance movements on a scale of 0 to 10, where 10 represents the highest ability to perform the movement and 0 means they are unable to do it. The results will provide a prevalence of hypermobility in kathak dancers and also a comprehensive view on its association with pain and kathak specific movement taking account of the dancers’ practice frequency and intensity level. |