Balance
Conditions
Keywords
shoe insert, orthotics, sway
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.
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.
Interventions
DEVICEexperimental 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.
Sponsors
Villency Design Group, LLC
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center of Mass Displacement (Sway) During Standing | 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 | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Healthy Men and Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 25.1 years STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: At 1 week of acclimation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Men and Women | Center of Mass Displacement (Sway) During Standing | .62 centimeters | Standard Deviation 0.24 |
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.
Time frame: At 1 week of acclimation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Men and Women | Center of Peak Speed of Displacement. | 8.58 centimeters per second | Standard Deviation 3.63 |
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
Time frame: At 1 week of acclimation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Men and Women | Center of Variability Displacement During Standing | .75 centimeters | Standard Deviation 0.13 |