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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03663816
Other study ID # OCR18420
Secondary ID AGR00011966
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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