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CTRI Number  CTRI/2025/09/094232 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study how walking with toe out can help reduce pain and improve functions in people with knee osteoarthritis. 
Scientific Title of Study   Effectiveness of 4 Week Toe Out Gait Modification on Pain and Function in Patients with Knee Osteoarthritis - Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srishti S Shetty  
Designation  Postgraduate student 
Affiliation  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy  
Address  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy,Institutional Area,Belpada Road,Sector 4,Kharghar,Navi Mumbai,Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  7738230018  
Fax    
Email  srishtshetty7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ezhil Mathi (PT) 
Designation  Principal, Professor  
Affiliation  Principal at Dr. G.D.Pol Foundation,YMT College of Physiotherapy  
Address  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy,Institutional Area,Belpada Road,Sector 4,Kharghar,Navi Mumbai,Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  9920302664  
Fax    
Email  ezhilmathi48@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Srishti S Shetty  
Designation  Postgraduate student 
Affiliation  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy  
Address  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy,Institutional Area,Belpada Road,Sector 4,Kharghar,Navi Mumbai,Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  7738230018  
Fax    
Email  srishtshetty7@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Srishti SShetty 
Address  Dr. G.D.Pol Foundation ,YMT College of Physiotherapy,Institutional Area,Belpada Road,Sector 4,Kharghar,Navi Mumbai,Maharashtra 
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 Srishti Shetty  Dr. G.D. Pol Foundation YMT College of Physiotherapy   305, Department of Musculoskeletal Physiotherapy (MSK OPD) ,YMT College Of Physiotherapy, Dr. G. D. Pol Foundation , Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 
7738230018

srishtshetty7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YMT COP Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Progressive walking  Participants will be made to walk with no fixed speed 4 times a week for 4 weeks 
Intervention  Toe Out Gait   Toe Out Gait Walking 4 times per week for 4 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Uniateral medial knee OA
2.Knee OA based on the radiographic evidence (Kellgren & Lawrence grade 1 and 2).
3.Adults ageing 45-70 years diagnosed with medial Knee OA
4.Toe out angle less or equal to 15 degrees
5.Ability to walk independently without assistive devices
 
 
ExclusionCriteria 
Details  1.Previous knee surgery or total knee replacement
2.History of lower limb fractures or neurological conditions affecting gait.
3.Participation in a structured exercise program within the last 3 month
4.Severe knee OA (Kellgren & Lawrence grade 4)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Numeric Pain Rating Scale (NPRS)
2.Western Ontario and McMaster Universities Osteoarthritis Index
3.Foot Progression Angle
4.Dynamic knee valgus  
At baseline and after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   15/09/2025 
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="1"
Months="0"
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  

Knee osteoarthritis is a prevalent musculoskeletal condition that significantly impacts mobility and quality of life. It is characterized by joint pain, stiffness, and functional impairment which often leads to reduced physical activity and increased disability. Conventional treatment approaches focus on pain management, physical therapy, and surgical interventions in severe cases. There is growing interest in biomechanical interventions aimed at modifying gait patterns to alleviate joint stress and slow disease progression. One such approach is toe out gait modification which involves externally rotating the foot during walking to alter load distribution within the knee joint. Previous studies have shown that toe out gait can reduce knee adduction moment and may have a protective effect against disease progression.

This study aims to evaluate the effectiveness of a 4 week toe out gait modification intervention in reducing pain and improving the quality of life in individuals with medial knee osteoarthritis.  The study population includes adults aged 45 to 70 years with unilateral medial knee osteoarthritis of Kellgren and Lawrence grade 1 and 2 who were able to walk independently. A total of 48 participants will be recruited and randomly allocated into two groups. Group A will receive toe out gait training along with conventional therapy while Group B will receive conventional therapy only. The intervention program will be conducted for 4 weeks with 4 sessions per week each lasting 40 to 45 minutes.

Outcome measures includes Numeric Pain Rating Scale NPRS, Western Ontario and McMaster Universities Osteoarthritis Index WOMAC, foot progression angle, and dynamic knee valgus. Data will be collected before and after the intervention and analyzed using appropriate statistical tests. The study is designed as a single blinded trial where participants were unaware of their allocation group.

 
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