| CTRI Number |
CTRI/2024/08/073142 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on Impact Of Different Heel Heights on Pain Status and on Foot Posture Impairments. |
|
Scientific Title of Study
|
Impact of Different Heel Heights on Visual Analogue Scale (VAS), and on Foot Posture Index. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Karmakar |
| Designation |
Student |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro Station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
9319331078 |
| Fax |
|
| Email |
gaurik2120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Pandey PT |
| Designation |
Assistant Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro Station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
9958556974 |
| Fax |
|
| Email |
vishal@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithvi Parasher PT |
| Designation |
Assistant Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro Station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
9625603419 |
| Fax |
|
| Email |
prithvi@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institute of Physiotherapy, Musculoskeletal Physiotherapy Department, Chnadiwala Estate, Maa Anandmayee Marg, Kalkaji, New Delhi, Delhi 110019 |
|
|
Primary Sponsor
|
| Name |
Gauri Karmakar |
| Address |
Chandiwala Estate, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019 |
| 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 Vishal Pandey |
Banarsidas Chandiwala Institute of Physiotherapy |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro Station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI |
9958556974
vishal@bcip.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banarsidas Chandiwala Institute of Physiotherapy Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1)Female of age group between 18-30 years of age.
2)Individuals with a history of symptomatic heel pain.
3)Individual who wear heels on a daily basis (at least 6 hours daily).
|
|
| ExclusionCriteria |
| Details |
1)Spinal problems such as spinal stenosis, herniated disk, or any fracture.
2)Lower limb injury such as fracture or any surgery (within 6 months).
3)Any individual already involved in any exercise program.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)VAS Scale to measure the pain intensity level
2)Foot posture index to measure foot deviation |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)VAS scale
2)Foot posture index |
6 month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
In today’s modern world, women of
different age group wear heels to make them look more fashionable and taller.
It has become a one of the common fashion habit that everyone is adopting these
days.
Some wear heels because of
their profession
and some wears heels as
a personal preference. Few associated problems are seen among the individuals
who wear different height heels such as low back pain, knee pain, pain their
calf muscles, and stiffness in the calf muscles.
The main purpose of this
research work is to study the changes seen in the pain level and in foot
posture index. The outcome of this study is that it will provide an impact on
the society by creating an awareness regarding the musculoskeletal problems
that are associated by wearing heels among young female adult population. |