DizzinessNCT02652442
Vestibular Rehabilitation and Otolith Dysfunction
A study testing Centrifugation Distance, Centrifugation Duration and Centrifugation Schedule in people with Dizziness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Recent studies suggest that otolith dysfunction is a common finding in individuals with a history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith dysfunction may be a significant health concern for the Veteran population, and determining optimal intervention strategies for otolith… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dizziness
- What is being tested?
- Centrifugation Distance, Centrifugation Duration and Centrifugation Schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2016to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Documented balance or mobility problems, or healthy control without imbalance
- Otolith dysfunction or healthy control without vestibular dysfunction
Who cannot join
- Progressive neurological disorders and central vestibular abnormalities
- Benign paroxysmal positional vertigo
- Superior semicircular canal dehiscence
- Middle-ear pathology with conductive hearing loss
- Lower extremity joint replacement
- Cognitive impairment (Mini Mental Status Exam < 24/30)
Show all 9Show fewer
- Severe depression (geriatric depression scale 10)
- Severe anxiety (geriatric anxiety inventory 11/30)
- Best-corrected visual acuity worse than 20/40 in the better eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, 37684
About this study
Recent studies suggest that otolith dysfunction is a common finding in individuals with a history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith dysfunction may be a significant health concern for the Veteran population, and determining optimal intervention strategies for otolith dysfunction is important for VA healthcare. The purpose of this project is to identify optimum stimulus parameters of a novel treatment, off-axis rotation (centrifugation) for otolith dysfunction, in healthy participants.
Read the detailed description
The primary function of the vestibular (inner ear balance) system is to maintain gaze and postural stability. The vestibular system is comprised of two types of sensory organs (semicircular canals and otolith organs) each with unique contributions to balance.
Vestibular Rehabilitation (VR) is the treatment of choice for patients experiencing dizziness, imbalance, and mobility impairments related to vestibular dysfunction. VR typically includes gaze stability exercises, gait and balance training, and general conditioning. Gaze stability exercises were developed based on the concepts of adaptation and substitution with the goal of improving gaze stability by facilitating vestibular compensation of the semicircular canal-mediated vestibulo-ocular reflex (VOR).
Many factors that might influence recovery, such as the involvement of different vestibular sensory organs (semicircular canals versus otolith organs) have not been examined to determine their impact on recovery. Most studies examining the effectiveness of VR have used only tests of VOR function (caloric and rotational tests) that measure horizontal semicircular canal to determine vestibular loss. Thus, little is known about interventions to facilitate vestibular compensation of the otolith organs.
Recent studies have demonstrated adaptation following otolith organ stimulation using centrifugation (or linear acceleration), but there is no data regarding optimum stimulus parameters. The concept of using centrifugation for otolith adaptation may be similar to using gaze stability exercises for VOR adaptation. Healthy control subjects (n = 5 per experiment) will participate in three separate experiments to determine: (1) the optimum off-axis distance of the rotary chair, (2) the optimum duration of off-axis rotation (OAR), and (3) the optimum OAR stimulation/training schedule.
- Conditions
- Dizziness
- Being tested
- Centrifugation Distance, Centrifugation Duration, Centrifugation Schedule
- Keywords
- dizziness, postural balance, rehabilitation
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centrifugation DistanceBehavioural
To determine optimal distance off-axis, participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 sessions in a 1-week period. Following a 2-week washout period, participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 sessions in a 1-week period.
Centrifugation DurationBehavioural
To determine optimal duration, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes. Participants received 5 sessions in a 1-week period.
Centrifugation ScheduleBehavioural
To determine optimal schedule, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes (determined to be optimal in Exp 2). Participants received biweekly sessions for a total of 5 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Centrifugation Parameters | Experimental | Three experiments were performed to identify optimal centrifugation parameters: (1) distance off-axis (3.5 vs 7 cm); (2) duration (1 min vs 3 mins); (3) schedule (daily vs biweekly). The comparisons were all within subjects; i.e., each subject was tested systematically for each centrifugation parameter under both conditions. The change in the outcome measure SVV (from pre- to post-off-axis rotation) for each condition (e.g., 3.5 vs 7 cm) within a parameter was compared. Receives: Behavioral: Centrifugation Distance; Behavioral: Centrifugation Duration; Behavioral: Centrifugation Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Static Subjective Visual Vertical (SVV)
Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function. Perception of vertical is measured in a darkened room with subject seated upright. The test assesses an individual's ability to adjust a laser line to be parallel with true vertical in the absence of any other visual cues. The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line in a vertical position. Five trials are completed, and the software calculates the distance (in degrees) from vertical. The average of the trials is calculated and used for data analysis.
Measured: baseline, immediately after 5 sessions of OAR training (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start4 Jan 2016
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- To determine optimal stimulus parameters for off-axis rotation (OAR), participants progressed through the study starting with off-axis distance (3.5 vs 7.0 cm), off-axis duration (1 vs 3 minutes) and finally training schedule (daily vs biweekly). SVV was measured immediately before and after training. To determine optimal distance, OAR was first performed at 3.5 cm and then 7.0 cm off-axis for 1 minute and the change in SVV compared. Participants trained daily for 5 consecutive days at 3.5 cm followed by a washout period of two weeks, then trained at 7.0 cm. To determine optimal duration, participants were rotated at 3.5 cm off-axis (determined to be optimal) for 3 minutes and the change in SVV was compared to 3.5 cm off-axis for 1 minute. To determine optimal training schedule, participants were rotated at 3.5 cm off-axis for 3 minutes (determined to be optimal) on a biweekly schedule for a total of 5 sessions and change in SVV was compared to the daily training schedule.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Courtney D Hall, PhD PT, Principal investigator, Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652442
- Sponsor's protocol ID
- C2058-P
- Status last verified
- Oct 2021
- First submitted
- 4 Jan 2016
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation and Otolith Dysfunction
- ClinicalTrials.gov ID
- NCT02652442
- Acronym / sponsor ID
- C2058-P
- Conditions
- Dizziness
- Keywords
- dizziness, postural balance, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies suggest that otolith dysfunction is a common finding in individuals with a history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith dysfunction may be a significant health concern for the Veteran population, and determining optimal intervention strategies for otolith dysfunction is important for VA healthcare. The purpose of this project is to identify optimum stimulus parameters of a novel treatment, off-axis rotation (centrifugation) for otolith dysfunction, in healthy participants.
Detailed description
The primary function of the vestibular (inner ear balance) system is to maintain gaze and postural stability. The vestibular system is comprised of two types of sensory organs (semicircular canals and otolith organs) each with unique contributions to balance.
Vestibular Rehabilitation (VR) is the treatment of choice for patients experiencing dizziness, imbalance, and mobility impairments related to vestibular dysfunction. VR typically includes gaze stability exercises, gait and balance training, and general conditioning. Gaze stability exercises were developed based on the concepts of adaptation and substitution with the goal of improving gaze stability by facilitating vestibular compensation of the semicircular canal-mediated vestibulo-ocular reflex (VOR).
Many factors that might influence recovery, such as the involvement of different vestibular sensory organs (semicircular canals versus otolith organs) have not been examined to determine their impact on recovery. Most studies examining the effectiveness of VR have used only tests of VOR function (caloric and rotational tests) that measure horizontal semicircular canal to determine vestibular loss. Thus, little is known about interventions to facilitate vestibular compensation of the otolith organs.
Recent studies have demonstrated adaptation following otolith organ stimulation using centrifugation (or linear acceleration), but there is no data regarding optimum stimulus parameters. The concept of using centrifugation for otolith adaptation may be similar to using gaze stability exercises for VOR adaptation. Healthy control subjects (n = 5 per experiment) will participate in three separate experiments to determine: (1) the optimum off-axis distance of the rotary chair, (2) the optimum duration of off-axis rotation (OAR), and (3) the optimum OAR stimulation/training schedule.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine optimal stimulus parameters for off-axis rotation (OAR), participants progressed through the study starting with off-axis distance (3.5 vs 7.0 cm), off-axis duration (1 vs 3 minutes) and finally training schedule (daily vs biweekly). SVV was measured immediately before and after training. To determine optimal distance, OAR was first performed at 3.5 cm and then 7.0 cm off-axis for 1 minute and the change in SVV compared. Participants trained daily for 5 consecutive days at 3.5 cm followed by a washout period of two weeks, then trained at 7.0 cm. To determine optimal duration, participants were rotated at 3.5 cm off-axis (determined to be optimal) for 3 minutes and the change in SVV was compared to 3.5 cm off-axis for 1 minute. To determine optimal training schedule, participants were rotated at 3.5 cm off-axis for 3 minutes (determined to be optimal) on a biweekly schedule for a total of 5 sessions and change in SVV was compared to the daily training schedule.
| Arm | Type | Receives |
|---|---|---|
| Centrifugation Parameters | Experimental | Behavioral: Centrifugation Distance, Behavioral: Centrifugation Duration, Behavioral: Centrifugation ScheduleThree experiments were performed to identify optimal centrifugation parameters: (1) distance off-axis (3.5 vs 7 cm); (2) duration (1 min vs 3 mins); (3) schedule (daily vs biweekly). The comparisons were all within subjects; i.e., each subject was tested systematically for each centrifugation parameter under both conditions. The change in the outcome measure SVV (from pre- to post-off-axis rotation) for each condition (e.g., 3.5 vs 7 cm) within a parameter was compared. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Documented balance or mobility problems, or healthy control without imbalance
- Otolith dysfunction or healthy control without vestibular dysfunction
Key exclusion criteria (9 listed)
- Progressive neurological disorders and central vestibular abnormalities
- Benign paroxysmal positional vertigo
- Superior semicircular canal dehiscence
- Middle-ear pathology with conductive hearing loss
- Lower extremity joint replacement
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 |
|---|---|---|
| Centrifugation DistanceTo determine optimal distance off-axis, participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 sessions in a 1-week period. Following a 2-week washout period, participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 sessions in a 1-week period. | Behavioural | Centrifugation Parameters |
| Centrifugation DurationTo determine optimal duration, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes. Participants received 5 sessions in a 1-week period. | Behavioural | Centrifugation Parameters |
| Centrifugation ScheduleTo determine optimal schedule, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes (determined to be optimal in Exp 2). Participants received biweekly sessions for a total of 5 sessions. | Behavioural | Centrifugation Parameters |
Primary outcome
Change in Static Subjective Visual Vertical (SVV)
Time frame: baseline, immediately after 5 sessions of OAR training (1 week)
Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function. Perception of vertical is measured in a darkened room with subject seated upright. The test assesses an individual's ability to adjust a laser line to be parallel with true vertical in the absence of any other visual cues. The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line in a vertical position. Five trials are completed, and the software calculates the distance (in degrees) from vertical. The average of the trials is calculated and used for data analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Courtney D Hall, PhD PT principal investigator
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centrifugation Distance, Centrifugation Duration and Centrifugation Schedule in people with Dizziness, run by VA Office of Research and Development 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 3 inclusion and 9 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 4 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Static Subjective Visual Vertical (SVV) (time frame: baseline, immediately after 5 sessions of OAR training (1 week)). 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 4 Nov 2021.