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

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.

Conditions

• Arthritis Knee

Interventions

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.

Sponsors & Collaborators

• Scientific Motion Technologies, Inc.

  collaborator INDUSTRY

• University of Florida

  lead OTHER

Principal Investigators

• Hari K Parvataneni · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-16

Primary Completion

2020-11-10

Completion

2020-11-10

FDA Device

Yes