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

Balance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663816
• Other study ID #: OCR18420
• Secondary ID: AGR00011966
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Villency Design Group, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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