VertigoNCT01080430
Effects of a Vestibular Rehabilitation Maneuver
A study testing rehabilitation maneuver in people with Vertigo, run by Day General Hospital. at 1 site in Iran.
Trial summary
Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. Using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Vertigo
- What is being tested?
- rehabilitation maneuver
- How many people
- 16 participants
- Where
- 1 siteIran
- Study dates
- Nov 2007to Mar 2009
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of vertigo for at least one year
- Not under drug therapy for vertigo
- directional preponderance >10% measured by electronystagmography during rotation test
Who cannot join
- severe vertigo
- intolerance to rotation
- previously diagnosed for a central pathology (e.g., neuroma)
- previously diagnosed with a fluctuating vestibular disorder (e.g., Menier's)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term and Long-term Effects of the Rotational Maneuver in Patients With Chronic Vestibular Imbalance
Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. Using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose that the rehabilitative effect is the result of a decrease in the vestibular imbalance, mainly due to a decrease in the response of the dominant vestibular side. Previously, we have shown the short-term effects of this maneuver on patients with recent onset vestibular imbalance. In the present study, we investigated the long-term effects of the rotational maneuver in patients with a history of peripheral vestibular vertigo for at least one year, originally confirmed by clinical tests. Our results show a significant improvement which lasted for >4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover, there seems to be a relationship between the decrease in DP values and a decrease in subjective symptoms. We propose that this maneuver can be used as an effective method for both short- and long-term rehabilitation.
- Conditions
- Vertigo
- Being tested
- rehabilitation maneuver
- Keywords
- vestibular, vertigo, rehabilitation, rotation, balance
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation maneuverOther
Also called rotatory maneuver
rotation in the direction of the weak vestibular response, every 3-7 days over a period of a month. Each rotation lasts about 2 minutes and a total of 3-7 rotations are used per session.
What is being measured
The primary outcome is the main question the study is designed to answer.
Directional preponderance (DP)
It provides an objective measure of vestibular asymmetry (percentage) in response to rotation. Eye movements are measured by electronystagmography during head rotations to the right and to the left. DP (%) is calculated by the equation: 100 x (max eye velocity for rightward rotations - max eye velocity for left rotations) / (max eye velocity for rightward rotations + max eye velocity for left rotations). Values below 10% are considered normal.
Measured: Every 3-7 days for one month
Secondary outcomes (1)
Subjective sense of a decrease in imbalance and dizziness.
Patients report the intensity and frequency of their symptoms as a measure of subjective improvement on a scale of 1 - 10, with 10 representing the most improvement.
Measured: every 3-7 days for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Day General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Dr Nayer Rassaian, Shahid Beheshti University of Medical Sciences
- Investigators
- Nayer Rassaian, MD, PhD, Principal investigator, Shaheed Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080430
- Sponsor's protocol ID
- DGH-VR02
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2010
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sadeghi NG, Sabetazad B, Rassaian N, Sadeghi SG. Rebalancing the Vestibular System by Unidirectional Rotations in Patients With Chronic Vestibular Dysfunction. Front Neurol. 2019 Jan 22;9:1196. doi: 10.3389/fneur.2018.01196. eCollection 2018.
PubMed 30723455
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Long-term Effects of the Rotational Maneuver in Patients With Chronic Vestibular Imbalance
- ClinicalTrials.gov ID
- NCT01080430
- Acronym / sponsor ID
- DGH-VR02
- Conditions
- Vertigo
- Keywords
- vestibular, vertigo, rehabilitation, rotation, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Day General Hospital.University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Mar 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.
Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. Using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose that the rehabilitative effect is the result of a decrease in the vestibular imbalance, mainly due to a decrease in the response of the dominant vestibular side. Previously, we have shown the short-term effects of this maneuver on patients with recent onset vestibular imbalance. In the present study, we investigated the long-term effects of the rotational maneuver in patients with a history of peripheral vestibular vertigo for at least one year, originally confirmed by clinical tests. Our results show a significant improvement which lasted for >4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover, there seems to be a relationship between the decrease in DP values and a decrease in subjective symptoms. We propose that this maneuver can be used as an effective method for both short- and long-term rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of vertigo for at least one year
- Not under drug therapy for vertigo
- directional preponderance >10% measured by electronystagmography during rotation test
Key exclusion criteria (4 listed)
- severe vertigo
- intolerance to rotation
- previously diagnosed for a central pathology (e.g., neuroma)
- previously diagnosed with a fluctuating vestibular disorder (e.g., Menier's)
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 |
|---|---|---|
| rehabilitation maneuverAlso: rotatory maneuverrotation in the direction of the weak vestibular response, every 3-7 days over a period of a month. Each rotation lasts about 2 minutes and a total of 3-7 rotations are used per session. | Other | – |
Primary outcome
Directional preponderance (DP)
Time frame: Every 3-7 days for one month
It provides an objective measure of vestibular asymmetry (percentage) in response to rotation. Eye movements are measured by electronystagmography during head rotations to the right and to the left. DP (%) is calculated by the equation: 100 x (max eye velocity for rightward rotations - max eye velocity for left rotations) / (max eye velocity for rightward rotations + max eye velocity for left rotations). Values below 10% are considered normal.
1 secondary outcome
Subjective sense of a decrease in imbalance and dizziness.
Time frame: every 3-7 days for one month
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 8 Feb 2019.
- Derived from this study: PubMed 30723455Sadeghi NG, Sabetazad B, Rassaian N, Sadeghi SG. Rebalancing the Vestibular System by Unidirectional Rotations in Patients With Chronic Vestibular Dysfunction. Front Neurol. 2019 Jan 22;9:1196. doi: 10.3389/fneur.2018.01196. eCollection 2018.
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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.
Nayer Rassaian, MD, PhD principal investigator
Shaheed Beheshti University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation maneuver in people with Vertigo, run by Day General Hospital. at 1 site in Iran.
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 4 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 8 Feb 2019. 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 Iran. 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?
Directional preponderance (DP) (time frame: Every 3-7 days for one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080430, which also lists 1 linked publication.
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 8 Feb 2019.