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NCT Number: NCT06741033

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of orthopedic and rehabilitation IOR garden town

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional physiotherapy

Diagnostic Test

Conventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy.

Toe-in gait modification

Combination Product

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.

Primary outcomes

  1. NUMERIC PAIN RATING SCALE (NPRS)

    Time frame: 12 Months

    The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine

  2. WOMAC scale

    Time frame: 12 Months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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