| CTRI Number |
CTRI/2024/10/075921 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To check that how much reliable and cross adaptation in different culture of the Gujarati version of the scale used to assess Hip Disability and Osteoarthritis outcome score in patient with Hip condition |
|
Scientific Title of Study
|
To Evaluate the Reliability and Cross Cultural Adaptation of Gujarati version of the Hip Disability and Osteoarthritis Outcome Score |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nerin Hansoti |
| Designation |
MPT Scholar |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Sevashram Hospital Parul Institute of Physiotherapy Parul University Limda Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
7096997207 |
| Fax |
|
| Email |
hansotinerin09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Choksi |
| Designation |
Assisstant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Sevashram Hospital Parul Institute of Physiotherapy Parul University Limda Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
7574861708 |
| Fax |
|
| Email |
prachi.choksi88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmang Vyas |
| Designation |
Assisstant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Sevashram Hospital Parul Institute of Physiotherapy Parul University Limda Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
8758958568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| 3rd floor, room no.305, Parul Institute of Physiotherapy, Parul University, pin 391760 Post Limda, Waghodia, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Hansoti Nerin Navinchandra |
| Address |
3rd floor, room no.305, Parul Institute of Physiotherapy, Parul University,pin 391760, Post Limda, Waghodia, Gujarat, India |
| 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 |
| Dr Nerin N Hansoti |
Parul institute of physiotherapy, parul university |
3rd floor, room no 305, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat, india
Vadodara
GUJARAT |
7096997207
hansotinerin09@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: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reliability and cross-cultural adaptation |
Translation of English version of Hip Disability and Osteoarthritis Outcome Score (HOOS) into Gujarati version and will check the reliability and cross-cultural adaptation of Gujarati version of HOOS scale within the duration of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 years and above
Participants of both genders (male and female) will be included
Diagnosed with any Hip surgery
Indications for primary THA
Subjects who will sign consent form willingly
Participants who can understand Gujrati language
|
|
| ExclusionCriteria |
| Details |
Patient suffering from Cerebrovascular storke
patient suffering from parkinsons disease
patient suffering from paraplegia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reliability of Gujarati version of Hip Disability and Osteoarthritis Outcome Score |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reliability of Gujarati version of Hip Disability and Osteoarthritis Outcome Score |
1 day last day of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/12/2024 |
| 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="6"
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
|
NEED OF STUDY The HOOS is a questionnaire intended to be used to assess patient’s opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during therapeutic process. This scale is used in conditions like THA Femoral neck fracture Hip osteoarthritis etc. Translation have needed to achieve effective communication between different cultures. Therapist have to first translate the scale into the native language and then have to explain it to the patient which consumes time of the therapist as well as patient. Translating this scale will help the therapist to convey the scale easily and properly to patients in their native language.
|