| CTRI Number |
CTRI/2024/09/074477 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability and Validity of Hindi Translated FAAM Questionnaire in Chronic Ankle Instability Patients. |
|
Scientific Title of Study
|
Hindi Translation, Validation and Test-Retest Reliability of Foot and Ankle Ability Measure (FAAM) Questionnaire in Patients with Chronic Ankle Instability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Uppal |
| Designation |
PG Student |
| Affiliation |
MMIPR, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
7206260872 |
| Fax |
|
| Email |
vanshikauppal2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
MMIPR, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Vanshika Uppal |
| Designation |
PG Student |
| Affiliation |
MMIPR, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
7206260872 |
| Fax |
|
| Email |
vanshikauppal2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, India, 133207 |
|
|
Primary Sponsor
|
| Name |
Vanshika Uppal |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, India, 133207 |
| 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 |
| Dr Sunita Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. |
room no: 05, General OPD Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala ,Haryana, India, 133207
Ambala
HARYANA |
9467633734
drsunita.sharma@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MMIMSR, Mullana, Ambala |
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 |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The ages of the subjects ranged from 25 to 60 years.
2. Patients with chronic ankle instability will be included.
3. Both males and females will be included.
|
|
| ExclusionCriteria |
| Details |
1. History of foot and ankle surgery
2. Un-cooperative patients.
3. Patients fluent in English
4. Psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot and Ankle Ability Measure (FAAM) Questionnaire |
10 Mins |
|
|
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)
|
30/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2024 |
| 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)
|
Open to Recruitment |
| 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
|
To translate the scale and assess the validity and reliability of the translated Hindi version of the Foot and Ankle Ability Measure Questionnaire in patients with Chronic Ankle Instability. |