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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Balance

Intervention / Treatment
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* Device: experimental foot device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy men and women<br>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<br>* Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people.<br>* Other names: proprioceptive foot device;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoe insert, orthotics, sway