FallsGyroNCT01188161
Postural Effects of Being Rotated in a Whole Body Gyroscope
An observational study of Falls and Balance, run by Carrick Institute for Graduate Studies at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls, Balance, Movement Disorders
- What is being tested?
- Rotating Chair
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Normal healthy volunteers without a history of vertigo or dizziness
Who may be able to join
- Normal Healthy Adults without a history of vertigo or dizziness
Who cannot join
- History of dizziness or vertigo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Whole Body Rotations in the Pitch and Yaw Planes on Postural Stability
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.
Read the detailed 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,
- Conditions
- Falls, Balance, Movement Disorders
- Being tested
- Rotating Chair
- Keywords
- Posturography, Balance, Falls, Gyroscope, Rotational Chair, Vestibular, Movement Disorders
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotating ChairDevice
Also called gyrostim
Subjects will be spun in rotating chair
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Volunteers without a history of dizzyness or vertigo Receives: Device: Rotating Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Dynamic Posturography
Standard platform posturography
Measured: 10 minutes after Rotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Investigators
- Stephanie Sullivan, DC, Study chair, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188161
- Sponsor's protocol ID
- 1-2010-06
- Acronym
- Gyro
- Status last verified
- Aug 2010
- First submitted
- 20 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Rotations in the Pitch and Yaw Planes on Postural Stability
- ClinicalTrials.gov ID
- NCT01188161
- Acronym / sponsor ID
- Gyro / 1-2010-06
- Conditions
- Falls, Balance, Movement Disorders
- Keywords
- Posturography, Balance, Falls, Gyroscope, Rotational Chair, Vestibular, Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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,
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | Device: Rotating ChairVolunteers without a history of dizzyness or vertigo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal healthy volunteers without a history of vertigo or dizziness
Key inclusion criteria (1 listed)
- Normal Healthy Adults without a history of vertigo or dizziness
Key exclusion criteria (1 listed)
- History of dizziness or vertigo
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 |
|---|---|---|
| Rotating ChairAlso: gyrostimSubjects will be spun in rotating chair | Device | Normal subjects |
Primary outcome
Computerized Dynamic Posturography
Time frame: 10 minutes after Rotation
Standard platform posturography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
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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.
Stephanie Sullivan, DC study chair
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls and Balance, run by Carrick Institute for Graduate Studies 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 1 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 25 Aug 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Computerized Dynamic Posturography (time frame: 10 minutes after Rotation). 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 25 Aug 2010.