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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01188161
Other study ID # 1-2010-06
Secondary ID
Status Completed
Phase N/A
First received August 20, 2010
Last updated August 23, 2010
Start date July 2010
Est. completion date August 2010

Study information

Verified date August 2010
Source Carrick Institute for Graduate Studies
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec. The effects of this rotation on the ability to stand upright will be measured.


Description:

Computerized dynamic posturography (CDP) testing will be obtained after practice sessions on all subjects using a CAPS Pro system (Vestibular Technologies, Cheyenne WY, USA). All tests will be conducted with the subject standing on a perturbing foam cushion. Six different conditions will be tested in sequence without the subjects stepping away from the foam/platform in order to assess if the center of sway position changed with the changing test conditions: (1) Eyes Open Head Neutral, (2) Eyes Closed Head Neutral, (3) Eyes Closed Head Right, (4) Eyes Closed Head Left, (5) Eyes Closed Head Flexed, (6) Eyes Closed Head Extended. Subjects will be continuously rotated in a computer-controlled multi-axis chair (Gyrostim by UltraThera Technologies, Inc.) in combinations of whole body Pitch and Yaw simultaneously over a 40 second profile at 90 deg/sec (15 RPM). The acceleration rates to 90 degrees per second as well as deceleration rates will be linear and occur in 1 second. We will utilize rotations that will represent all combinations of pitch and yaw with Pitch direction changing two times and Yaw direction four times (Backward Pitch -20 seconds with right Yaw-10 seconds to left Yaw-10 seconds, to Forward Pitch- 20 seconds with right Yaw-10 seconds to left Yaw 10 seconds). Post rotational CDP testing will be compared to the Pre Rotational CDP,


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Normal Healthy Adults without a history of vertigo or dizziness

Exclusion Criteria:

- History of dizziness or vertigo

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Device:
Rotating Chair
Subjects will be spun in rotating chair

Locations

Country Name City State
United States Life University Marietta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Carrick Institute for Graduate Studies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Computerized Dynamic Posturography Standard platform posturography 10 minutes after Rotation Yes
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