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Clinical Trials/CTRI/2025/09/094232
CTRI/2025/09/094232
Not yet recruiting
Not Applicable

Effectiveness of 4 Week Toe Out Gait Modification on Pain and Function in Patients with Knee Osteoarthritis - Randomized Controlled Trial

Dr Srishti SShetty1 site in 1 country48 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Srishti SShetty
Enrollment
48
Locations
1
Primary Endpoint
1.Numeric Pain Rating Scale (NPRS)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
45.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

1.Numeric Pain Rating Scale (NPRS)

Time Frame: At baseline and after 4 weeks

2.Western Ontario and McMaster Universities Osteoarthritis Index

Time Frame: At baseline and after 4 weeks

3.Foot Progression Angle

Time Frame: At baseline and after 4 weeks

4.Dynamic knee valgus

Time Frame: At baseline and after 4 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Srishti SShetty
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Srishti S Shetty

Dr. G.D.Pol Foundation ,YMT College of Physiotherapy

Study Sites (1)

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