| CTRI Number |
CTRI/2024/10/075859 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
heel pain in Telugu version |
|
Scientific Title of Study
|
Cross Cultural adaptation, translation and Psychometric evaluation of the Telugu version of Foot Function Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vajrala Krishna Reddy |
| Designation |
Associate professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Plot no:2, Sector 17A, Yamuna Expressway, Greater Noida, Gautambudd nagr, Uttarpradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
7799233734 |
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vajrala Krishna Reddy |
| Designation |
Associate professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Plot no:2, Sector 17A, Yamuna Expressway, Greater Noida, Gautambudd nagr, Uttarpradesh
UTTAR PRADESH 203201 India |
| Phone |
7799233734 |
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vajrala Krishna Reddy |
| Designation |
Associate professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Plot no:2, Sector 17A, Yamuna Expressway, Greater Noida, Gautambudd nagr, Uttarpradesh
UTTAR PRADESH 203201 India |
| Phone |
7799233734 |
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vajrala Krishna Reddy |
Physiotherapy OPD, Galgotias University |
Department of physiotherapy, room no E005,Plot no:2, Sector 17A, Yamuna Expressway, Greater Noida, Gautambudd nagr, Uttarpradesh Gautam Buddha Nagar UTTAR PRADESH |
7799233734
krishnareddympt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics CommiPttee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M20-M25||Other joint disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Foot pain |
|
| ExclusionCriteria |
| Details |
Fracture
Trauma or Injury |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot Function Index |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS |
Baseline & after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1. Introduction The purpose of this protocol is to outline the steps involved in the cross-cultural adaptation, translation, and psychometric analysis of the Foot Function Index (FFI) in Telugu, India. The FFI is a validated tool used to assess foot function and related disability. Adapting and translating the FFI into Telugu will enable its use in Telugu-speaking populations, ensuring cultural appropriateness and validity. 2. Cross-Cultural Adaptation Process The cross-cultural adaptation process involves the following steps: Step 1: Permission and Collaboration Obtain permission from the MAPI trust to proceed with the adaptation process. Seek collaboration from experts in foot and ankle research and Telugu language specialists. Step 2: Translation Engage bilingual translators proficient in English and Telugu to independently translate the original FFI into Telugu. Aim for two or more independent translations to ensure multiple perspectives. Step 3: Synthesis Form a committee consisting of translators, experts, and a methodologist. Review the independent translations and compare them to identify discrepancies and areas of disagreement. Develop a consensus version of the translated FFI through discussion and consensus among the committee members. Step 4: Back-Translation Engage bilingual translators who are native English speakers and fluent in Telugu. Provide them with the consensus version of the translated FFI and instruct them to independently back-translate it into English. Step 5: Expert Committee Review Convene the expert committee to review the back-translated English version in comparison to the original FFI. Identify any discrepancies and discuss potential cultural and linguistic differences. Step 6: Pretesting Administer the pre-final version of the translated FFI to a sample of 30 target population (Telugu-speaking individuals). Collect feedback on comprehension, cultural relevance, and clarity of the items. Modify the translated FFI based on the feedback received. |