N/A
Completed N=15
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Balance
Source: ClinicalTrials.gov NCT03663816 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Center of Mass Displacement (Sway) During Standing — .62 centimeters
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.
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 | — |
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
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. Informational only — not medical advice.