| CTRI Number |
CTRI/2023/11/059426 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
01/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Tamil Version of Foot Function Index |
|
Scientific Title of Study
|
Cross Cultural Adaptation,Translation and Psychometric analysis of Foot Function Index in Tamil |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T S Veeragoudhaman |
| Designation |
Dean |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Dean Office,V Floor, SRM College of Physiotherapy,SRM Institute of Science and Technology,Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500375408 |
| Fax |
|
| Email |
veeragot@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinitha Arasu |
| Designation |
Clinical Physiotherapist |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
C-1 20 ,Department of Physiotherapy,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology,Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
8637488187 |
| Fax |
|
| Email |
vinithaa@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vinitha Arasu |
| Designation |
Clinical Physiotherapist |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
C-1 20 ,Department of Physiotherapy,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology,Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
8637488187 |
| Fax |
|
| Email |
vinithaa@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,SRM Institute of Science and Technology,Kattankulathur |
|
|
Primary Sponsor
|
| Name |
TSVeeragoudhaman |
| Address |
Dean Office, SRM College of Physiotherapy, V Floor, SRM Medical College, SRM Institute of Science and Technology, Kattankulathur -603 203 |
| 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 |
| DrTSVeeragoudhaman |
SRM College of Physiotherapy,SRM Institute of Science and Technology |
V Floor, SRM College of Physiotherapy,SRM Medical College Building, SRM Institute of Science and Technology,Kattankulathur - 603 203
Kancheepuram
TAMIL NADU |
9500375408
veeragot@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Language proficiency: Participants should be native Tamil speakers or individuals fluent in Tamil, as they will be required to
understand and respond to the translated FFI questionnaire.
2. Age range: Specify the age range that is relevant to your study. For example, participants could be adults aged 18 to 65 years or a specific subgroup within that range.
3. Foot-related condition:
Include individuals who have a foot-related condition or injury that affects their foot function. This could include conditions such as
plantar fasciitis, ankle sprains, or other foot-related problems.
4. Clinical diagnosis: Participants should have received a clinical diagnosis of the foot-related condition from a qualified healthcare
professional. This ensures that participants have a confirmed condition that can be assessed using the FFI.
5. Willingness to participate: Participants should be willing to take part in the study and comply with the study procedures, including completing the translated FFI questionnaire and any follow-up assessments or interviews.
6. Ability to provide informed consent: Participants should have the capacity to understand the study purpose, procedures, and potential risks involved. They should be able to
provide informed consent or have a legally authorized representative who can provide consent on their behalf. |
|
| ExclusionCriteria |
| Details |
1. Inability to understand or communicate in Tamil: Participants who do not have sufficient proficiency in Tamil to understand the
translated FFI questionnaire or providing meaningful responses should be excluded.
2. Cognitive impairment: Individuals with severe cognitive impairment or neurological conditions that impair their ability to comprehend and
respond to the questionnaire accurately may be excluded.
3. Medical contraindications: Exclude individuals who have medical conditions or physical limitations that prevent them from completing
the FFI questionnaire or participating in the study procedures safely.
For example, individuals with severe foot deformities or amputations that significantly affect foot function may be excluded.
4. Participation in a similar study: Exclude individuals who have participated in a similar cross-cultural adaptation or translation study
of the FFI questionnaire to avoid duplicating data or potential bias from prior exposure to the instrument.
5. Concurrent participation in another research study: Exclude individuals who are currently participating in another research study that may interfere with their ability to fully engage in the pilot study.
6. Inability to provide informed consent: Exclude individuals who lack the capacity to understand the purpose, risks, and procedures of the study and cannot provide informed consent, or who do not have a legally authorized representative available to provide consent on their behalf. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Disability
Foot Function Index |
Baseline and Forty eight hours later test and re-test reliability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion of Ankle and Subtalar joint |
Baseline and seventy two hours |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
12/11/2023 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Title: Cross-Cultural Adaptation, Translation, and Psychometric Analysis of the Foot Function Index in
Tamil
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 Tamil. The FFI is a validated tool used to
assess foot function and related disability. Adapting and translating the FFI into Tamil will enable its use
in Tamil-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 original developers of the FFI to proceed with the adaptation process. Seek
collaboration from experts in foot and ankle research and Tamil language specialists.
Step 2: Translation
Engage bilingual translators proficient in English and Tamil to independently translate the original FFI
into Tamil. 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 Tamil. 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 the target population (Tamil-
speaking individuals). Collect feedback on comprehension, cultural relevance, and clarity of the items.
Modify the translated FFI based on the feedback received.
3. Psychometric Analysis
Once the adapted and translated FFI is finalized, it is important to assess its psychometric properties to
ensure validity and reliability. This involves the following steps:
Step 1: Sampling
Determine the desired sample size based on statistical considerations. Aim for a representative sample
of Tamil-speaking individuals across different age groups, genders, and foot-related conditions.
Step 2: Data Collection
Administer the finalized Tamil version of the FFI to the selected sample. Collect demographic
information and ensure standardized procedures for data collection to minimize bias.
Step 3: Reliability Analysis
Assess the internal consistency reliability of the Tamil FFI using statistical methods such as Cronbach’s
alpha. This analysis measures the extent to which items in the FFI are interrelated.
Step 4: Construct Validity Analysis
Evaluate the construct validity of the Tamil FFI by assessing its correlation with other established foot-
related measures or clinical assessments. Use appropriate statistical techniques such as correlation
coefficients or factor analysis.
Step 5: Test-Retest Reliability
Assess the test-retest reliability of the Tamil FFI by re-administering the questionnaire to a subsample of
participants after a specified interval. Calculate the intraclass correlation coefficient (ICC) to determine
the degree of agreement between the two administrations.
Step 6: Cultural Adaptation Report
Prepare a comprehensive report summarizing the cross-cultural adaptation process, translation
procedure, and psychometric analysis results. Include recommendations for the use of the Tamil FFI in
research and clinical practice.
4. Conclusion
This protocol outlines the steps involved in the cross-cultural adaptation, translation, and psychometric
analysis of the Foot Function Index (FFI) in Tamil. Adapting and validating the FFI in Tamil will enable its
accurate assessment of foot function and related disability among Tamil-speaking individuals,
contributing to more culturally sensitive research and healthcare practices. |