| CTRI Number |
CTRI/2025/03/082488 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Translation and adaptation of MHHS in Kannada |
|
Scientific Title of Study
|
Translation and Cross - cultural adaptation of Modified
Harris Hip Score(MHHS) Scale in Kannada |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohamed Ajmal PV |
| Designation |
MPT |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy Department, yenepoya (Deemed to be
university), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895469187 |
| Fax |
|
| Email |
ajmalajuznmk007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. R. Sathyaraja |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy Department, yenepoya (Deemed to be
university), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9150908049 |
| Fax |
|
| Email |
rsathyaraja@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr. R. Sathyaraja |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy Department, yenepoya (Deemed to be
university), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9150908049 |
| Fax |
|
| Email |
rsathyaraja@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 Mohamed Ajmal PV |
Yenepoya Medical College Hospital |
Department of
orthopedic Department
of geriatric and
Department of
physiotherapy
University road,
Deralakatte ,
Mangaluru-575018
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9895469187
ajmalajuznmk007@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
|
|
|
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Both Male and Female Gender are included
2.Patient with femoral neck fracture, THR and hip abnormalities. |
|
| ExclusionCriteria |
| Details |
1.Patients with serious associated disease.
2.Patients with other conditions like trauma, hip infection, any neurological disease and other Musculoskeletal problems.
3.Patients who are uncooperative and not willing for the study.
4.Not being able to read and write the questionnaire. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| modified Harris hip score scale |
on day 1 and after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
18/04/2025 |
| 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)
|
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
|
Modified Harris hip score scale 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 Modified Harris hip score scale into the Kannada language using the beaton Guidelines. Further, the study will assess the test-retest reliability of the Kannada version of the Modified Harris hip score scale. 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. |