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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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