NCT03663816

Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking

Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy.

Detailed description

This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy. Healthy participants will wear this insole device in their own athletic/tennis shoes over the course of one week. There are two key purposes of this study: 1. To determine how using this insole device for 1 week may effect a healthy individual's balance and postural sway while standing; and 2. To determine how using this insole device for 1 week may effect how an individual walks (gait), how hard they hit the ground as they walk, and foot pressure patterns with each step. Each individual's balance, postural sway, and walking gait (how you walk) will be analyzed before and after wearing the shoe insole device for the one-week time period.

Conditions

• Balance

Interventions

Type	Name	Description
DEVICE	experimental foot device	Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2018-09-10
• Last updated: 2021-05-03
• Results posted: 2021-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study