| CTRI Number |
CTRI/2025/08/093942 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability testing of the Gujarati Lysholm Knee Scoring Scale in individuals with knee osteoarthritis |
|
Scientific Title of Study
|
Cross-cultural translation and reliability of Gujarati version of the Lysholm Knee Scoring Scale in Knee Osteoarthritis individuals :- A Correlation Study |
| Trial Acronym |
G-LKS( OA) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushi Nileshbhai Jobanputra |
| Designation |
Student |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Parul Institute Of Physiotherapy- Limda, Waghodia , Vadodara
Parul Sevashram Hospital, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9510487998 |
| Fax |
|
| Email |
khushijobanputra248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Noopur Bhatt |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Parul Institute Of Physiotherapy- Limda, Waghodia , Vadodara
Parul Sevashram Hospital , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9601146785 |
| Fax |
|
| Email |
noopurbhattphysiolife@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Noopur Bhatt |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Parul Institute Of Physiotherapy- Limda, Waghodia , Vadodara
Parul Sevashram Hospital, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9601146785 |
| Fax |
|
| Email |
noopurbhattphysiolife@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Khushi Nileshbhai Jobanputra |
Parul sevasharam hospital |
Parul Institute Of Physiotherapy- Limda, Waghodia , Vadodara
Vadodara
GUJARAT |
09510487998
khushijobanputra248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scale Translation |
Step 1: To take the permission of the author for translating LKS scale
into Gujarati version.
Step 2: Forward translation (English-Gujarati)
An expert in Gujarati language will translate the
original English version of LKS into Gujarati.
Step 3: Backward translation (Gujarati-English)
An expert in both English and Gujarati language will
verify the translated Gujarati version of LKS from
original English version.
Step 4: Seek feedback from native Gujarati speakers, especially with the medical
background to ensure the translated LKS scale is clear and culturally
relevant.
Step 5: Based on the feedback, finalize the Gujarati version of the LKS scale.
Step 6: The psychometric properties (reliability ) of the LKS scale will be check .
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
• Diagnosed cases of osteoarthritis of the knee (as per clinical or radiological criteria).
• Age group: [Specify age range, e.g., 55–75 years].
• Gujarati-speaking individuals.
• Willing to provide informed consent.
• Able to understand and respond to the questionnaire.
|
|
| ExclusionCriteria |
| Details |
• History of knee surgery or recent trauma.
• Presence of any neurological disorder affecting gait or knee function.
• Rheumatoid arthritis or other inflammatory joint diseases.
• Severe cognitive impairment or psychiatric illness.
• Individuals who have undergone knee replacement surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For reliability – Test and Re-test [ using intra class relation coefficient]
|
For reliability – Test and Re-test [ using intra class relation coefficient]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
Study Duration: 1 year • Study Population: Knee Osteoarthritis • Sample Size :- 160 participants • Source of sample: Parul Sevashram Hospital and any Multi speciality hospital in Vadodara • Method: Step 1: To take the permission of the author for translating LKS scale into Gujarati version. Step 2: Forward translation (English-Gujarati) An expert in Gujarati language will translate the original English version of LKS into Gujarati. Step 3: Backward translation (Gujarati-English) An expert in both English and Gujarati language will verify the translated Gujarati version of LKS from original English version. Step 4: Seek feedback from native Gujarati speakers, especially with the medical background to ensure the translated LKS scale is clear and culturally relevant. Step 5: Based on the feedback, finalize the Gujarati version of the LKS scale. Step 6: The psychometric properties (reliability) of the LKS scale will be check . |