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

NCT03663816 | Completed Results DMC FDA Device

• 2 other identifiers: OCR18420AGR00011966
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Balance

Keywords

shoe insert; orthotics; sway

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Healthy men and women

EXPERIMENTAL

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

Interventions

experimental foot device 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.

Also known as: proprioceptive foot device

Healthy men and women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Villency Design Group, LLC: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Results Point of Contact

• Title: Sharareh Sharififar
• Organization: University of Florica

sharareh75@phhp.ufl.edu

352-273-7410

Study Officials

• Heather Vincent, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 10, 2018
• Study Start: October 1, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Locations

US (1)