- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080430
Effects of a Vestibular Rehabilitation Maneuver
February 6, 2019 updated by: Dr Nayer Rassaian, Day General Hospital.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of
- Vestibular and auditory center of Day General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of vertigo for at least one year
- Not under drug therapy for vertigo
- directional preponderance >10% measured by electronystagmography during rotation test
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Directional preponderance (DP)
Time Frame: Every 3-7 days for one month
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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.
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Every 3-7 days for one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective sense of a decrease in imbalance and dizziness.
Time Frame: every 3-7 days for one month
|
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.
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every 3-7 days for one month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nayer Rassaian, MD, PhD, Shaheed Beheshti University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 3, 2010
First Submitted That Met QC Criteria
March 3, 2010
First Posted (Estimate)
March 4, 2010
Study Record Updates
Last Update Posted (Actual)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 6, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGH-VR02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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