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

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

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.

Study Overview

• Status: Completed
• Conditions: Balance
• Intervention / Treatment: Device: experimental foot device

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).

Exclusion Criteria:

• Moderate or severe obesity (body mass index >35kg/m2)
• Known diagnosis of cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that impacts normal walking ability
• Any current ankle, knee, hip or low back pain
• Currently using any knee or ankle brace on a regular basis for joint pains
• Severe back pain, prior spinal fusion or spinal deformity that would affect gait
• Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
• Any major orthopedic injury within the prior 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy men and women; Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device	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.; Other Names: proprioceptive foot device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center of Mass Displacement (Sway) During Standing	Two-foot stance, Single foot balance, and Tandem stance- Once the data are collected, calculations of center of mass displacement (in cm) will be determined. These values will provide insight about direction of sway and how quickly sway occurs during these three balance conditions.	At 1 week of acclimation
Center of Variability Displacement During Standing	Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined	At 1 week of acclimation
Center of Peak Speed of Displacement.	Two-foot stance, Single foot balance, and Tandem stance- and the peak speed of displacement (cm per second) will be determined.	At 1 week of acclimation

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Villency Design Group, LLC
• Investigators: Principal Investigator: Heather Vincent, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: orthotics; shoe insert; sway
• Other Study ID Numbers: OCR18420; AGR00011966 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes