Trial Outcomes & Findings for Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking (NCT NCT03663816)

Last Updated: 2021-05-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

At 1 week of acclimation

Results posted on

2021-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Men and Women n=15 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.1 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 week of acclimation

Outcome measures

Outcome measures
Measure	Healthy Men and Women n=15 Participants 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.
Center of Mass Displacement (Sway) During Standing	.62 centimeters Standard Deviation .24

PRIMARY outcome

Timeframe: At 1 week of acclimation

Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined

Outcome measures

Outcome measures
Measure	Healthy Men and Women n=15 Participants 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.
Center of Variability Displacement During Standing	.75 centimeters Standard Deviation .13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Men and Women n=15 Participants 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.
Center of Peak Speed of Displacement.	8.58 centimeters per second Standard Deviation 3.63

Adverse Events

Healthy Men and Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharareh Sharififar

University of Florica

Phone: 352-273-7410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place