| CTRI Number |
CTRI/2024/11/076949 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
translating the hip disability and osteoarthritis outcome score-12 scale into kannada language and testing its reliability |
|
Scientific Title of Study
|
Translation and Test-Retest Reliability of the Kannada version of Hip Disability and Osteoarthritis Outcome Score-12 Scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECR/J337/Inst/KA/2020 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sauda |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya (Deemed to be) university |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018.
Yenepoya Medical college Hospital, Department of Physiotherapy, Deralakatte, Mangaluru-575018.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7676543720 |
| Fax |
|
| Email |
saudanawab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M R Sivakumar |
| Designation |
Assosiate Professor Stage-1 |
| Affiliation |
Yenepoya (Deemed to be) university |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018.
Yenepoya Medical college Hospital, Department of Physiotherapy, Deralakatte, Mangaluru-575018.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448386457 |
| Fax |
|
| Email |
mrsivakumar@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M R Sivakumar |
| Designation |
Assosiate Professor Stage-1 |
| Affiliation |
Yenepoya (Deemed to be) university |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018.
Yenepoya Medical college Hospital, Department of Physiotherapy, Deralakatte, Mangaluru-575018.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448386457 |
| Fax |
|
| Email |
mrsivakumar@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yenepoya physiotherapy college |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru-575018. |
| Type of Sponsor |
Private medical college |
|
|
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 M R Sivakumar |
Yenepoya Medical College Hospital |
Department of orthopedic Department of geriatric and Department of physiotherapy University road, Deralakatte , Mangaluru-575018
Dakshina Kannada
KARNATAKA |
7676543720
saudanawab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with Hip and disabilities for at least 3months.
2.Patient with Total Hip Replacement.
3.Participant should know the Kannada language |
|
| ExclusionCriteria |
| Details |
1.Patients with serious associated disease like cancer, HIV, cardiovascular disease, metabolic disease.
2.Patient with trauma, hip infection, any neurological disease leading to uncooperative patients.
3.Lower limb abnormalities.
4. Any other Musculoskeletal problems
5. back related problems |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hip disability and osteoarthritis outcome score 12 item |
on day 1 and after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Hip disability and osteoarthritis outcome score- 12 items is one of the most commonly used for recording the health-related quality of life in individuals with hip osteoarthritis and Total hip replacement. The study aims to translate the hip disability and osteoarthritis outcome score-12 items into the Kannada language using the Mapi Research Institute Linguistic Evaluation Guidelines. Further, the study will assess the test-retest reliability of the Kannada version of the Hip disability and osteoarthritis outcome score-12 items. The Kannada version of the scale thus developed will be helpful in the assessment and management of individuals with hip osteoarthritis and THR whose native language is Kannada. |