BalanceNCT03663816
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
A study testing experimental foot device in people with Balance, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- experimental foot device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
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.
Read the 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
- Being tested
- experimental foot device
- Keywords
- shoe insert, orthotics, sway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental foot deviceDevice
Also called proprioceptive 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: experimental foot device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: At 1 week of acclimation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Oct 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Villency Design Group, LLC
- Responsible party
- Sponsor
- Investigators
- Heather Vincent, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663816
- Sponsor's protocol ID
- OCR18420
- Other IDs
- AGR00011966
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2018
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
- ClinicalTrials.gov ID
- NCT03663816
- Acronym / sponsor ID
- OCR18420
- Conditions
- Balance
- Keywords
- shoe insert, orthotics, sway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Villency Design Group, LLC
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 3 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy men and women | Experimental | Device: experimental foot deviceParticipants 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental foot deviceAlso: proprioceptive foot deviceAppropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people. | Device | Healthy men and women |
Primary outcome
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.
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Vincent, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental foot device in people with Balance, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Mass Displacement (Sway) During Standing (time frame: At 1 week of acclimation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.