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

University of Florida

Status: Completed

Conditions: Balance

Treatments: Device: experimental foot device

Study type: Interventional

Funder types: Other

Identifiers

NCT03663816

OCR18420

AGR00011966 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Healthy men and women

Experimental group

Description:

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

Treatment:

Device: experimental foot device