| CTRI Number |
CTRI/2024/10/076010 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigating the Impact of Exercise Interventions on Correcting Muscle-Induced Out-toeing Gait in College Students |
|
Scientific Title of Study
|
Assessing the influence of Exercise Interventions on Muscle Induced Out-toeing Gait in College 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 |
Mohammed Ansar PT |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
University road. Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
University road Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7034331352 |
| Fax |
|
| Email |
ansaranzil99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Harsha M Naik |
| Designation |
Assosciate Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
University road. Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
University road Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8073836187 |
| Fax |
|
| Email |
harshamnaik@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mohammed Ansar PT |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
University road. Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
University road Derlakatte, Ullal, Karnataka Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7034331352 |
| Fax |
|
| Email |
ansaranzil99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, Nanngana (Mangalore) Dakshina kannada (Karnataka) pincode: 575018 India |
|
|
Primary Sponsor
|
| Name |
Mohammed Ansar P T |
| Address |
University road, Deralakatte, Ullal, Karnataka 575018 |
| 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 Harsha M Naik |
Yenepoya Physiotherapy Collage(deemed to be university) |
Physiotherapy OPD,7th floor,Yenepoya Medical Collage, Deralakatte ,Dakshina Kannada,Karnataka Dakshina Kannada KARNATAKA |
8073836187
harshamnaik@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students with out-toeing gait |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
For combine stretching and strengthening exercises for single group |
In this single arm study, participants will follow an 8-week program combining both stretching and strengthening exercises. The stretching exercises, such as the Figure of 4 stretch, target the piriformis and hamstrings to improve joint mobility and alignment. Each stretch will be held for 30 seconds, with four repetitions and a 10-second rest between sets. Alongside the stretching, participants will perform strengthening exercises targeting the hip and tibial internal rotators, including clamshells, bridges, side-lying leg raises, squats, and step-ups. These exercises will be done 3-5 times a week, with 10-15 repetitions per set and 3 sets for each exercise. The goal is to enhance muscle strength, alignment, and gait mechanics. Both the stretching and strengthening exercises will be provided to the same group to assess their combined effectiveness. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants with no current musculoskeletal
injuries affecting lower limbs.
Those willing to engage in a structured exercise program. |
|
| ExclusionCriteria |
| Details |
Individuals outside the specified age range.
Pre-existing medical conditions affecting gait (e.g.,neurological
disorders).
History of lower limb surgery within the past year.
Pregnancy or any medical condition restricting physical activity.
Participants involved in regular strenuous physical training outside
the study.
History of pain in lower limb
History of surgery in lower limb |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome measures for the research project "Assessing the influence of Exercise Interventions on Muscle Induced Out-toeing Gait in College Students" include:
External Rotation (degrees) - Measured by Goniometer
Internal Rotation (degrees) - Measured by Goniometer
Hip Strength (lbs/kg) - Measured by Dynamometer
Distance Between Legs (in/cm) - Measured by Inch Tape |
All outcomes will be measured both before the intervention (pre-intervention) and after 8 weeks (post-intervention) to evaluate the effectiveness of the exercise program. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/11/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Out-toeing gait, is a condition where the feet point outward during walking. This gait abnormality can be caused by muscle imbalances in the hip and lower limbs, such as weak internal rotators or tight external rotators. Among young adults, like college students, these imbalances can lead to discomfort, inefficient movement, and a higher risk of future musculoskeletal problems. This experimental study aims to assess the effect of targeted exercise interventions on muscle-induced out-toeing gait in college students. This study explored how a structured 8-week exercise program could help correct out-toeing gait caused by muscle imbalances in college students aged 18 to 25. Thirty-four physiotherapy students with noticeable out-toeing were selected through purposive sampling. Before and after the program, their hip rotation, muscle strength, and the distance between their feet were measured using standard tools like goniometers, dynamometer (Chattilon Mechanical Dynamometer DMG), and measuring tapes. The participants followed a specific physiotherapy routine focused on hip stretching and strengthening exercises. After the intervention, there were significant improvements in hip movement range, muscle strength, and foot alignment. These results suggest that a simple, non-invasive exercise program can effectively improve walking patterns and lower limb alignment in young adults with muscle-related gait issues. |