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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  
NA 
 
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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M20-M25||Other joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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