Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06251167

A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis

Led by University of British Columbia · Updated on 2026-06-01

31

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

W

Western University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people aged 50 and older with knee osteoarthritis who also experience foot pain. The study aims to assess the feasibility and early effects of shoe-worn insoles on symptoms and biomechanics at both the knee and foot joints. This multi-center randomized pilot trial is led by the University of British Columbia to explore ways to relieve pain and improve function in affected individuals. Two types of insoles are being tested. One group receives lateral wedge insoles (LWIs) that have a 6-degree wedge on the outer edge. The other group receives lateral wedge plus custom arch support (LWAS) insoles, which combine the 6-degree wedge with a tailored arch support made using advanced 3D scanning and printing technology. Participants will wear their assigned insoles in their own shoes for at least 5 hours daily over 3 months. During the study, participants will undergo assessments at the start and after 3 months, including self-reported knee and foot pain, physical and foot function, and walking speed. Biomechanical measurements such as knee moments and foot motion will also be recorded. Researchers will track recruitment, retention, and the time needed to deliver insoles. This comprehensive approach will help determine the insoles' impact and the study's feasibility over the trial period.

CONDITIONS

Brief Title

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Medial tibiofemoral osteoarthritis confirmed by X-rays showing osteophytes and joint space narrowing
  • History of knee pain lasting longer than 6 months
  • Average knee pain of at least 3 out of 10 over the past 6 months
  • Pain in the same foot or feet as the painful knee(s)
  • Ability to communicate in English
  • Show an immediate biomechanical response to the insoles during an in-person assessment
Not Eligible

You will not qualify if you...

  • Evidence of more lateral tibiofemoral osteoarthritis than medial
  • Knee surgery or intra-articular injection within the previous 6 months
  • Current or recent corticosteroid use within 6 months
  • Presence of any systemic arthritic condition
  • History of knee joint replacement or tibial osteotomy
  • Any other condition affecting lower limb function
  • Current use of shoe-worn insoles or planning to get footwear modifications within 6 months
  • Previous use of insoles that caused increased lower limb pain or led to stopping their use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 months

Participants will be asked to wear shoe-worn insoles in their own shoes for at least 5 hours per day to improve clinical and biomechanical features of knee osteoarthritis.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, Canada, V5R 3N9

Actively Recruiting

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Research Team

N

Natasha Krowchuk

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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