| CTRI Number |
CTRI/2025/02/081286 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Footwear choices and its association with foot posture and musculoskeletal discomfort in working men and women |
|
Scientific Title of Study
|
Footwear choices and its association with foot posture and musculoskeletal discomfort in working adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Kohli |
| Designation |
PG Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
08130874881 |
| Fax |
|
| Email |
garykohli25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Amity School Of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida Uttar Pradesh. Gautam Buddha Nagar UTTAR PRADESH 201313 India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
9878529787 |
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Amity School of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
UTTAR PRADESH 201313 India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
9878529787 |
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Amity Institute of Health Allied Sciences
Amity University Noida
Amity Rd, Sector 125, Noida, Uttar Pradesh 201301
India |
|
|
Primary Sponsor
|
| Name |
Garima Kohli |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| 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 |
| Dr Pragya Kumar |
Amity University Noida |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH |
9878529787
pkumar24@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
25-45 working adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age range: 25-45years
Both men and Women |
|
| ExclusionCriteria |
| Details |
Individuals involved in Sports
Presence of any diagnosed foot related congenital deformities
History of diagnosed neurological disorders
History of lower extremity surgeries or fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Footwear Assessment Tool |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Foot Posture Index
|
4 weeks |
| Nordic Musculoskeletal Questionnaire |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
10/03/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Need of the Study – The purpose of this study is to examine the relationship between footwear choices, their combined effects on foot posture and musculoskeletal discomfort in working adults.. Although prior research has explored the impact of footwear on either foot issues or musculoskeletal discomfort individually, the joint influence of these factors has received limited attention, underscoring the importance of this research. Aims - To identify association of footwear choices with foot posture and musculoskeletal discomfort in working adults. Objectives- I. To determine association of footwear choices with foot posture in working adults. II. To determine association of footwear choices with musculoskeletal problems in working adults. Hypothesis – Null hypothesis -There will no significant association between footwear choices, foot posture and musculoskeletal discomfort in working adults. Alternate hypothesis- There will a significant association between footwear choices, foot problems and musculoskeletal discomfort in adults. |