Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge.
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles.
Motion Analysis and Biofeedback Laboratory
Vancouver, British Columbia, Canada
RECRUITINGRecruitment - number of screened patients who are eligible
The number of screened patients determined eligible to be enrolled in the study.
Time frame: from onset of recruitment through study completion
Retention - proportion of assessments with complete outcome measures data
Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.
Time frame: immediately after the intervention
Insoles Delivery
Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study.
Time frame: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months
Self-reported knee pain
Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Time frame: Baseline, 3 Months
Self-reported foot pain
Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
Time frame: Baseline, 3 Months
External knee adduction moment impulse
The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach.
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Time frame: Baseline, 3 Months
Self-reported overall physical function
Physical function will be measured by the Function, Daily Living subscale (17 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Time frame: Baseline, 3 Months
Self-reported foot function
Foot function will be measured at baseline and at 3-months by the Activity Limitations subscale (3 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
Time frame: Baseline, 3 Months
External knee flexion moment impulse
The external knee flexion moment impulse will be calculated using the same methods as described for the external knee adduction moment impulse.
Time frame: Baseline, 3 Months
Self-selected gait speed
Self-selected gait speed will be calculated during the biomechanical gait analyses.
Time frame: Baseline, 3 Months
Rearfoot eversion peak
Participants will walk on an instrumented walkway while high speed cameras track the trajectories of markers placed on bony landmarks.
Time frame: Baseline, 3 Months