N/A N=15 Other

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

Balance

Bottom Line

View on ClinicalTrials.gov: NCT03663816 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Center of Mass Displacement (Sway) During Standing — .62 centimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: experimental foot device (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Center of Mass Displacement (Sway) During Standing	.62	—
PRIMARY Center of Variability Displacement During Standing	.75	—
PRIMARY Center of Peak Speed of Displacement.	8.58	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03663816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.