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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663816
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Villency Design Group, LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Balance Device: experimental foot device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: 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
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.
Other Name: proprioceptive foot device




Primary Outcome Measures :
  1. Effect of an experimental foot device on center of mass displacement (sway) during standing [ Time Frame: 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

  2. Effect of an experimental foot device on center of variability displacement during standing [ Time Frame: At 1 week of acclimation ]
    Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined

  3. Effect of an experimental foot device on center of peak speed of displacement. [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663816


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Villency Design Group, LLC
Investigators
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Principal Investigator: Heather Vincent, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03663816    
Other Study ID Numbers: OCR18420
AGR00011966 ( Other Identifier: University of Florida )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Florida:
shoe insert
orthotics
sway