| CTRI Number |
CTRI/2025/08/092917 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hindi translation of western ontario shoulder instability index (WOSII) |
|
Scientific Title of Study
|
HINDI TRANSLATION, VALIDATION AND RELIABILITY OF WESTERN ONTARIO SHOULDER INSTABILITY INDEX (WOSII) IN PATIENTS WITH SHOULDER INSTABILITY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Jalota |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana, Haryana, Ambala, India
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Haryana, Ambala, India
Ambala
HARYANA
133207
India |
| Phone |
7973514927 |
| Fax |
|
| Email |
jalotaankita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala, Haryana, India
Room No. 2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala, Haryana, India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala, Haryana, India
Room No. 2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala, Haryana, India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ankita Jalota |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana 133207 |
| 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 |
| Ankita Jalota |
Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation |
Room No. 2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA |
7973514927
jalotaankita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences And Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with any form of shoulder instability (anterior, posterior, inferior or multidirectional)
2. Individuals who experienced atleast one or recurrent episodes of shoulder dislocation and disabled by apprehension
3. Individuals with a basic understanding of Hindi language |
|
| ExclusionCriteria |
| Details |
1. Non native Hindi speakers
2. Patients with neurological disorders
3. Patients with language or cognitive impairments
4. Patients with shoulder fracture or shoulder arthritis
5. Patients with impairments in the cervical spine, elbow or hand affecting the shoulder function
6. Patients with any other major illness that would influence quality of life of the patient
7. Patients with any psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Western Ontario Shoulder Instability Index |
After 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/08/2025 |
| 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="8"
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 shoulder is the most mobile and inherently unstable joint in the body, often leading to recurrent instability that affects functional status and quality of life. The Western Ontario Shoulder Instability Index (WOSI), developed by Kirkley et al. in 1998, is a disease-specific, patient-reported outcome measure used to assess quality of life in individuals with shoulder instability. Although the WOSI Index is available in several languages, a validated Hindi version is currently lacking, limiting its use among Hindi-speaking populations in India. Therefore, this study aims to translate the WOSI Index into Hindi and evaluate its validity and test-retest reliability through a cross-sectional design. The translation process will follow standard protocols, including forward and backward translation by bilingual experts, synthesis of translations, and review by a Delphi panel. The pre-final version will undergo field testing on patients to assess content validity, followed by statistical evaluation of reliability and validity, and ethical approval. |