| CTRI Number |
CTRI/2025/04/085755 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Balance and Knee Problems in Young College Men and Women with Foot Posture Issues |
|
Scientific Title of Study
|
A Cross-Sectional Study on the Correlation Between Balance and Knee Instability in Individuals With Altered Foot Posture Among Young Collegiate Male and Female Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Mahto |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. 316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9289497252 |
| Fax |
|
| Email |
Priya.mahto@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MuskanYadav |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No. 316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9079672966 |
| Fax |
|
| Email |
muskany385@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Mahto |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. 316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08057366428 |
| Fax |
|
| Email |
Priya.mahto@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha
International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India ,203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No2, Sector 17A Opposite Buddha International International Circuit, Greater Noida, Buddha Nagar, Uttar Pradesh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Priya Mahto |
Galgotias University |
Room No E004, Department of Physiotherapy, School of Allied Health Science,
Galgotias University,
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
08057366428
Priya.mahto@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental research committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Altered foot posture (female)(male) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range: Typically, these college students are between the ages of 18 and 25.
2. Gender participants, both male and female.
3. Student Status: Must be enrolled full-time in an institution of higher learning.
4. Condition of Health: Individuals who have not experienced any musculoskeletal conditions or injuries over the last six months affecting the hip, knee, ankle, or foot.
5. Level of Physical Activity: To account for differences in physical fitness, participants should have similar baselines in physical activity (e.g., at least 30 minutes of moderate activity, 3-5 times per week).
6. Uniformity of Footwear: To prevent shoe variances from causing inconsistencies, study participants should wear similar types of shoes, such as basic athletic footwear.
7. Consent given voluntarily: willingness to give informed consent and take part in the study. |
|
| ExclusionCriteria |
| Details |
1. Historical Injuries: Exclusion of those who have had recent lower extremity surgery, fractures, sprains, or rips in their ligaments.
2. Chronic illnesses: those who have been diagnosed with long-term ailments like scoliosis, arthritis, or congenital foot abnormalities.
3. Neurological Conditions: Individuals suffering from balance-related problems such as vertigo, neurological abnormalities, or vestibular dysfunction.
4. Deviation in Footwear: Exclusion of people wearing braces, orthotics, or other medical devices that alter the alignment of the knee or foot when walking or standing.
5. Maternity (in women): excludes expectant mothers owing to potential alterations in balance and body mechanics during pregnancy.
6. Incapacity or Lack of Will to Adhere to Protocol: Individuals who are unable to follow study protocol or who do not comply with it (e.g., specified altered foot postures). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot Posture Index (FPI-6)
Modified Four-Square Step Test (mFSST)
rotational, pivot shift (jerk), stress, and sliding tests
|
AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the difference in orientation patterns across different foot posture categories |
AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
08/05/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This cross-sectional study examines the effects of different foot postures on knee instability and balance in young female and male college students, ages 18 to 25. Changes in the arches of the feet from their neutral position, or altered foot posture. It may result in serious social, psychological, and physical difficulties. This population’s altered foot posture will be evaluated, and its relationship to altered foot posture (as measured by the FPI-6), balance (as measured by the mFSST), and knee instability (as measured by the pivot shift (jerk), stress, and slide tests) will be investigated. Individuals who have had recent pregnancies, surgeries, or other chronic foot issues are not eligible. The results should draw attention to the often-overlooked effects of changed foot position in young men and women, supporting early diagnosis and treatment to enhance physical health, gait patterns, and general quality of life. |