| CTRI Number |
CTRI/2018/10/016020 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
12/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation of lysholm knee scoring scale in Gujarati version in Knee ligaments injury . |
|
Scientific Title of Study
|
Cross- Cultural Transition , Reliability And Validity Of Gujarati Version Of The “Lysholm Knee Scoring Scale†(G-LKS) In ACL
And Meniscus Injury :A Correlation Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjun Patel |
| Designation |
Post Graduate |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9909418441 |
| Fax |
|
| Email |
apatel944@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Krupa Tank |
| Designation |
Assistant Professor, School of Physiotherapy RK. University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9998810063 |
| Fax |
|
| Email |
krupa.tank@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arjun Patel |
| Designation |
Post Graduate |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9909418441 |
| Fax |
|
| Email |
apatel944@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India |
|
|
Primary Sponsor
|
| Name |
Arjun Patel |
| Address |
School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, 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 |
| Arjun Patel |
RK Physiotherapy Rehabilitation and Research Center |
Bhaktinagar Circle, Opp. to Meghani Rangbhavan, Rajkot
Rajkot
GUJARAT |
9909418441
apatel944@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of knee symptoms(ACL and Meniscus injury)
2. Subjects native language should be Gujarati.
3. Indian citizen of Gujarat.
|
|
| ExclusionCriteria |
| Details |
1. Illiterate or lack of understanding of Gujarati language.
2.The presence of neurologic or musculoskeletal disorders other than the ACL and Meniscus injury.
3.Inability to complete the forms as a result cognitive impairment.
4.Individual not receiving treatment between test and retest. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lysholm knee scoring scale |
Day 1: To be assessed before the treatment is given by the First interviewer and after 45 min Second interviewer will assess outcome
On Day:2 To be assessed before the treatment is given only by the First interviewer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/10/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be carried out in five phases: the
first will be forward translation English to Gujarati. Second will be
synthesis of questionnaire. Third will be backward translation from
Gujarati to English. Fourth will be expert committees review. Fifth
will be a pilot study on individuals with ACL and Meniscus injury to
assess the comprehensibility of the Pre final version, and reliability and validity will be check.
|