| CTRI Number |
CTRI/2022/03/041102 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation and Testing of the Kannada Version of Lower Extremity Functional Scale |
|
Scientific Title of Study
|
Cross- Cultural Adaptation of the Lower Extremity Functional Scale in Kannada and assessment of its Measurement Properties-A Longitudinal Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Glenisha Ancita Dsouza |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy
Kasturba Medical College Mangalore
Center of basic sciences bejai,Mangalore-575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7760798979 |
| Fax |
|
| Email |
glenishadsouza07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy, Kasturba medical college, Mangalore
Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Eapen |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy, Kasturba medical college, Mangalore
Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
light house hill road mangalore 575001 |
| 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 |
| Glenisha Ancita Dsouza |
Kasturba Medical College and Hospital Mangalore |
Department of Physiotherapy
2nd floor
KMC Hospital Attavar
Dakshina Kannada
KARNATAKA |
7760798979
glenishadsouza07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Kasturba medical college Mangalore |
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
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) participants who can read kannada and whose native language is kannada, 2) patients with hip and knee conditions. 3) Age more than 18 years |
|
| ExclusionCriteria |
| Details |
1) Inability to complete the questionnaire due to cognitive impairment 2) Patients with neurological conditions affecting strength and motor control |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Lower Extremity Functional Scale-Kannada |
baseline
2-3days
7-10 days
discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
22/03/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The first phase will involve translating the English version of the LEFS in Kannada using standardized and accepted guidelines. The English language LEFS will be translated into Kannada by two translators who identify Kannada as their first language and English as their second language after which one synthesized version will be obtained after reconciling with the primary investigator. This synthesized version will be translated back to English by two translators who speak English routinely. the two back translations will be compared with the original LEFS to determine any inconsistencies and adjusted with the synthesized version.in the next step an expert committee will intervene to check if appropriate methodology is followed and develop the pre-final version of LEFS-K. the last step will involve assessment of prefinal LEFS-K in a sample of 10 lay individuals who are not from rehabilitation background and speak both Kannada and English. the individuals will be asked to describe the meaning of all questions In the LEFS-K compare the similarity of each item of LEFS-K to the matching item of the English LEFS and rate their satisfaction with each translated item on a numeric rating scale scoring from 0 to 10. These individuals will be asked to suggest an appropriate translation in case their response is less than or equal to 8. Following these steps , any final adjustments to the LEFS-K will be made and final version of the LEFS-K will be derived. The second phase will be the measurement properties of the LEFS-K using a longitudinal study design. patients presenting with hip and knee conditions will be included after baseline assessment. participants will complete LEFS-K,NRS-P,NRS-D, range of motion and 5-repetition sit to stand test.0n day 2 -4 participants will complete LEFS-K,NRS-P and NRS-D. participants will again complete LEFS-K,NRS-P,NRS-D,Global rate of change and1 question on satisfaction at 7-10days interval after baseline assessment as well as again at discharge from physiotherapy once hip/knee symptoms have improved. |