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Completed

NCT Number: NCT03663816

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

experimental foot device

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

Primary outcomes

  1. Center of Mass Displacement (Sway) During Standing

    Time frame: At 1 week of acclimation

    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.

  2. Center of Variability Displacement During Standing

    Time frame: At 1 week of acclimation

    Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined

  3. Center of Peak Speed of Displacement.

    Time frame: At 1 week of acclimation

    Two-foot stance, Single foot balance, and Tandem stance- and the peak speed of displacement (cm per second) will be determined.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Villency Design Group, LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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