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

Not Applicable

Completed

• Conditions: Balance
• Interventions: Device: experimental foot device

• Registration Number: NCT03663816
• Lead Sponsor: University of Florida

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Study Start: 2018-10-01
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Results First Submitted: 2020-11-17
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Results First Posted: 2021-05-03
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy men and women	experimental foot device	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

Primary Outcome Measures

Name	Time	Method
Center of Peak Speed of Displacement.	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.
Center of Mass Displacement (Sway) During Standing	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.
Center of Variability Displacement During Standing	At 1 week of acclimation	Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States