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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080430
Other study ID # DGH-VR02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2007
Est. completion date March 2009

Study information

Verified date February 2019
Source Day General Hospital.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
rehabilitation 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.

Locations

Country Name City State
Iran, Islamic Republic of Vestibular and auditory center of Day General Hospital Tehran

Sponsors (2)

Lead Sponsor Collaborator
Day General Hospital. Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Every 3-7 days for one month
Secondary 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. every 3-7 days for one month
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