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| ID | Type | Description | Link |
|---|---|---|---|
| AGR00011966 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Villency Design Group, LLC | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Vincent, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | centimeters | At 1 week of acclimation |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharareh Sharififar | University of Florica | 352-273-7410 | sharareh75@phhp.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 | Nov 17, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2018 | Apr 20, 2020 | ICF_000.pdf |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | All races accepted | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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 | Posted | Mean | Standard Deviation | centimeters | At 1 week of acclimation |
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| Primary | 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. | Posted | Mean | Standard Deviation | centimeters per second | At 1 week of acclimation |
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| 0 |
| 15 |
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| 15 |
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| 15 |
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