| 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
|
|
|
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
|
|
|
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
|
|
|
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. |