Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO

Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial Knee Osteoarthritis

Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Diagnostic test: Conventional physiotherapy; Combination product: Toe-in gait modification

Detailed Description

Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Institute of orthopedic and rehabilitation IOR garden town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
• Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
• Age > 45
• Ability to walk unaided for at least 25 min
• Gender eligibility both male and female

Exclusion Criteria:

• Severe MKOA (Grade 4)
• Lateral OA
• Patella femoral OA
• Previous or planned hip or knee surgery
• Hip or ankle arthritis
• Rheumatoid arthritis
• Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
• Neurological dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group I	Diagnostic test: Conventional physiotherapy; Conventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy.
Active Comparator: Interventional group II	Combination product: Toe-in gait modification; A specific alteration in walking pattern where the toes are directed inward during walking. This modification should be clearly defined, including the degree of inward rotation of the foot and how it is taught and monitored in participants. Toe-in gait modification basically includes decrease foot progression angle from baseline through internal foot rotation. Participants are instructed to increase the Toe-in angle of their study limb by 5 degree and walk at least 5-10 minutes (progressed to 15-20 min after 4 week) with this progression angle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NUMERIC PAIN RATING SCALE (NPRS)	The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine	12 Months
WOMAC scale	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness, and Physical Function) The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MSRSW/Batch-Fall22/758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No