| CTRI Number |
CTRI/2024/05/066704 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation Validation and Test-Retest Reliability of Foot Function Index Questionnaire |
|
Scientific Title of Study
|
Hindi Translation Validation and Test-Retest Reliability of Foot Function Index (FFI) Questionnaire for Patients with Plantar Fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanam Maurya |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
General outpatient department (OPD) Room no.4 Maharishi
Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar Deemed to be University Mullana
Ambala
Ambala
HARYANA
133207
India |
| Phone |
7009550221 |
| Fax |
|
| Email |
mauryasanam737@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemend to be University Ambala
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemend to be University Ambala
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markendeshwar Institute of Physiotherapy and Research |
|
|
Primary Sponsor
|
| Name |
Sanam Maurya |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana |
| 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 |
| Sanam Maurya |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
General OPD Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala Inida 133207
Ambala
HARYANA |
7009550221
mauryasanam737@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, MMIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.The ages of the subject ranged from 20 to 40 years.
2.Patients with plantar fasciitis will be included.
Both male and female will be included. |
|
| ExclusionCriteria |
| Details |
1.History of foot and ankle surgery
2.Patients with ankle sprain, strain foot disorders.
Un-cooperative patients. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hindi version Foot Function Questionnaire |
10 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
18/06/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To translate the scale and assess the validity and reliabilty of the translated hindi version
|