| CTRI Number |
CTRI/2024/02/062686 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
cross-cultural adaptation |
| Study Design |
Other |
|
Public Title of Study
|
translation of LEFS into Hindi language and checking adaptation in the local population and evaluating its validity and reliability |
|
Scientific Title of Study
|
Translation and Cross Cultural Adaptation, Reliability and Validity of Hindi version of Lower Extremity Functional Scale |
| Trial Acronym |
H-LEFS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashleen Kaur Sandhu |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9779977070 |
| Fax |
|
| Email |
yashleenksandhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Simranjeet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be) University, Mullana-Ambala, Haryana, India |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9877144498 |
| Fax |
|
| Email |
dr.simranjeet.kaur@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Yashleen Kaur Sandhu |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9779977070 |
| Fax |
|
| Email |
yashleenksandhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal OPD of Maharishi Markandeshwar Institue of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Yashleen Kaur Sandhu |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 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 |
| Yashleen Kaur Sandhu |
Maharishi Markandeshwar deemed to be university ,mullana, Ambala |
Department of orthopedic physiotherapy, MMIPR
Ambala
HARYANA |
9779977070
yashleenksandhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients suffering from lower limb musculoskeletal conditions which affect their quality of life
2 Both males and females who are able to perform their basic ADLs
3 Cooperative patients
4 Patient between the age group of 18-65 yrs.
5 Patients who are comprehensive to the English language
|
|
| ExclusionCriteria |
| Details |
1 Patients who do not speak and understand English and Hindi language
2 Patients having any musculoskeletal condition of the upper limb and spine
3 Patients having cognitive behavior problems
4 Patients having psychological conditions
5 Patients who don’t cooperate
6 Bedridden patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
•Lower Extremity Functional Scale (LEFS)
•36- Item Short Form Survey (SF-36) |
CONCURRENT VALIDITY baseline
ADAPTATIBILTY baseline
INTER-RATER baseline
INTRA- RATER 2 times with 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hindi version of LEFS |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/03/2024 |
| Date of Study Completion (India) |
30/03/2024 |
| Date of First Enrollment (Global) |
19/03/2024 |
| Date of Study Completion (Global) |
30/03/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
I am working on the translation of LEFS into Hindi language. For this permission was taken from the developer of LEFS. Steps that were taken for translation of the scale were: preparation of draft, forward translation (original LEFS into Hindi language), compilation of drafts(all the corrections and modifications that were suggested was compiled), backward translation (translated draft into English for the language verification). This process obtains a pre final draft. Content validation is done by Delphi method. After receiving the CTRI no. patients will be recruited for the process of concurrent validation, cross-culture adaptation and reliability. 12 patients will be recruited for cross-cultural adaptation. 30 patients will be recruited for concurrent validation. 52 patients: 26 for inter-rater reliability and 26 for intra-rater reliability will be taken. |