NCT03760380

Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.

Detailed description

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis. The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.

Conditions

• Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Sole 1 - Neutral	Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability.
DEVICE	Sole 1 - Offset	Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
DEVICE	Sole 2 - Neutral	Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability.
DEVICE	Sole 2 - Offset	Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.

Timeline

• Start date: 2019-04-16
• Primary completion: 2020-11-10
• Completion: 2020-11-10
• First posted: 2018-11-30
• Last updated: 2020-11-12

Regulatory

• FDA-regulated device study