| CTRI Number |
CTRI/2023/07/054720 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of shoes on coordination and foot pressure in collegiates |
|
Scientific Title of Study
|
Impact of footwear on coordination and foot pressure distribution among young adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-5909 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gargi Sahu |
| Designation |
Postgraduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, Neurological Physiotherapy Department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana- Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8889573457 |
| Fax |
|
| Email |
gargi.gs.26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, Neurological Physiotherapy Department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana- Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, Neurological Physiotherapy Department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana- Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Gargi Sahu |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala, Haryana |
| 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 |
| Gargi Sahu |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room No.2, Biomechanics Lab, MMIPR, MM(DU), Mullana- Ambala, Haryana
Ambala
HARYANA |
8889573457
gargi.gs.26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee (IEC) of Maharishi Markandeshwar Institute of Medical Science and Research (MMIMSR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with age 18-25 years, Healthy adults, Able to walk independently, Both Male and Female, Subjects wearing sports shoes for at least six hours a day for 5 days a week for more than 6 months, Able to follow verbal commands, MMSE>24
|
|
| ExclusionCriteria |
| Details |
Vestibular Abnormalities, Any musculoskeletal, cardiovascular and neurological impairments, Any surgical history of lower limb, Any visual deficit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Podia Scan, Harris Mat, Tandem Walking, Sideways Walking, Heel Walking, Toe Walking
|
3 readings on single day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
18/07/2023 |
| 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="7"
Days="0" |
|
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
|
Footwear choice and characteristics have an influence on the gross motor skills in the long run. Footwear design, comfort, fitting and other factors have been established to affect balance and equilibrium. Use of equilibrium coordination tests and foot loading to determine shoe designing can prove to be useful. To find out the impact of footwear on coordination and foot pressure distribution among young adults. Ninety five college-going students (age group = 18-25 years) will be recruited for the study. Subjects will be asked to perform heel walking, toe walking, tandem walking and sideways walking tests under barefooted and shod conditions to assess coordination. Then foot pressure distribution will be determined through Harris mat and Podiascan software. Three trials for each tests will be conducted. Six regions of the foot - hindfoot, lateral midfoot, lateral, central, medial forefoot and hallux will be evaluated for foot pressure distribution. Kolmogorov-Smirnov test will be used to determine normality. If the data is found to be normally distributed, the parametric test will be used. The paired t-test will be used to find the impact of footwear on the variables. If the data is not found to be normally distributed, non-parametric tests, such as the Wilcoxon Signed rank test, will be used.
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