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Effects of a Vestibular Rehabilitation Maneuver

Primary Purpose

Vertigo

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
rehabilitation maneuver
Sponsored by
Day General Hospital.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vertigo focused on measuring vestibular, vertigo, rehabilitation, rotation, balance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vestibular and auditory center of Day General Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 3, 2010
Last Updated
February 6, 2019
Sponsor
Day General Hospital.
Collaborators
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01080430
Brief Title
Effects of a Vestibular Rehabilitation Maneuver
Official Title
Short-term and Long-term Effects of the Rotational Maneuver in Patients With Chronic Vestibular Imbalance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Day General Hospital.
Collaborators
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
vestibular, vertigo, rehabilitation, rotation, balance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
rehabilitation maneuver
Other Intervention Name(s)
rotatory maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Directional preponderance (DP)
Description
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.
Time Frame
Every 3-7 days for one month
Secondary Outcome Measure Information:
Title
Subjective sense of a decrease in imbalance and dizziness.
Description
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.
Time Frame
every 3-7 days for one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayer Rassaian, MD, PhD
Organizational Affiliation
Shaheed Beheshti University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestibular and auditory center of Day General Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30723455
Citation
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.
Results Reference
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Effects of a Vestibular Rehabilitation Maneuver

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