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

NCT ID: NCT03663816

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-03-15

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.

Conditions

Balance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy men and women

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

Group Type: EXPERIMENTAL

experimental foot device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

proprioceptive foot device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Villency Design Group, LLC

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Vincent, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AGR00011966

Identifier Type: OTHER

Identifier Source: secondary_id

OCR18420

Identifier Type: -

Identifier Source: org_study_id