| CTRI Number |
CTRI/2025/02/081334 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of gait retraining on functional outcomes in patients with knee osteoarthritis |
|
Scientific Title of Study
|
Effects of gait retraining on functional outcomes in patients with medial arthritic degeneration of the knee joint. |
| 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 sachin gupta |
| Designation |
Assistant professor |
| Affiliation |
Galgotias University |
| Address |
Room No. B228, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17a, Greater Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr lovekush singh |
| Designation |
Research Student |
| Affiliation |
Galgotias University |
| Address |
Room no-E005 Department of Physiotherapy School of Allied Health Sciences Galgotias University
SECTOR, 17-A, YAMUNA EXPRESSWAY, GAUTAM BUDDHA NAGAR, GREATER NOIDA, NATIONAL CAPITAL REGION - 203201, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8920296809 |
| Fax |
|
| Email |
lksingh3825@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sachin gupta |
| Designation |
Assistant professor |
| Affiliation |
Galgotias UUniversity |
| Address |
Room No. B228, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17a, Greater Noida, Uttar Pradesh, India
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University
Sector, 17-A, Yamuna Expressway, Gautam Buddha Nagar, Greater Noida, National Capital Region - 203201, India |
|
|
Primary Sponsor
|
| Name |
Galgotias university |
| Address |
Room no. A315 Research and Development cell, Galgotias University
Sector, 17-A, Yamuna Expressway, Gautam Budhh Nagar, Greater Noida, National Capital Region - 203201, India |
| 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 Sachin Gupta |
Galgotias university |
Department of physiotherapy, Galgotias university yamuna expressway, opposite Buddha international Circuit, sector 17A greater Noida Uttar Pradesh, plot no.2 Gautam Buddh nagar Galgotias university yamuna expy, plot no.2, sector 17A
Gautam Buddha Nagar
UTTAR PRADESH
203201
Gautam Buddha Nagar
UTTAR PRADESH |
9015193829
sachingupta@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercises for osteoarthritis |
Static quadriceps muscle exercise
Static hamstring muscle exercise
Straight leg raise
Prone straight leg raise
Prone knee bending
Static Hamstrings Muscle Exercise
Ankle Toe Movements
Dynamic Quadriceps (Single Leg)
Isotonic Quadriceps (Both Legs)
Repeat all the exercise 10 times for 1 set thrice a day for 6 weeks |
| Intervention |
Gait retraining for osteoarthritis |
eversion walking or medial foot walking10-15 minutes per session and 3 sessions per day for 6 weeks
Static quadriceps muscle exercise Static hamstring muscle exercise Straight leg raise Prone straight leg raise Prone knee bending Static Hamstrings Muscle Exercise Ankle Toe Movements Dynamic Quadriceps (Single Leg) Isotonic Quadriceps (Both Legs) Repeat all the exercise 10 times for 1 set thrice a day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults aged 40 to 65 years
2 Clinically diagnosed with medial knee osteoarthritis, based on the American College of Rheumatology criteria.
3 Radio graphic evidence of medial compartment knee degeneration.
4 Ability to walk independently without assistive devices |
|
| ExclusionCriteria |
| Details |
1 Significant lateral or patella femoral compartment involvement.
2 Recent knee surgery (within the past 6 months).
3 Severe comorbidity affecting mobility (e.g., neurological disorders, severe cardiovascular conditions).
4 Participation in other physical therapy or intervention trials. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The five-time Sit to Stand test. Walking speed. |
baseline to post-intervention at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/03/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Effect of Gait Retraining on Functional Outcomes in Patients with Medial Arthritic Degeneration of the Knee Joint
Gait retraining is a therapeutic intervention aimed at modifying walking patterns to reduce knee loading and improve functional outcomes in patients with medial knee osteoarthritis (OA). This synopsis explores the impact of gait retraining on knee joint loading, pain reduction, and overall functional ability.
Key Points
1. Gait Retraining Techniques: Various techniques such as toe-in gait, toe-out gait, lateral trunk lean, and medial thrust gait are employed to reduce the knee adduction moment (KAM), which is often elevated in medial knee OA.
2. Biomechanical Effects: Gait retraining has been shown to reduce medial knee loading without adversely affecting the hip and ankle joints. This reduction in KAM can lead to decreased pain and improved joint function
3. Biofeedback Integration: Incorporating biofeedback, such as real-time knee moment feedback, enhances the effectiveness of gait retraining by providing patients with immediate information on their gait patterns 4. Clinical Outcomes: Studies have demonstrated that a six-week gait retraining program can significantly improve functional outcomes, reduce pain, and enhance the quality of life for patients with medial knee OA
5. Patient Adherence: The ease of implementing gait retraining techniques and the patient’s adherence to the program are crucial factors in achieving positive outcomes
Visual Representation
To complement your synopsis, consider including images such as: - Diagrams illustrating the biomechanical changes in gait patterns. - Photographs of patients undergoing gait retraining sessions. - Graphs showing the reduction in KAM and improvement in functional outcomes.
These visuals will help provide a comprehensive understanding of the benefits and mechanisms of gait retraining for medial knee OA.
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