NCT01080430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

March 3, 2010

Last Update Submit

February 6, 2019

Conditions

Vertigo

Keywords

vestibularvertigorehabilitationrotationbalance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subjective sense of a decrease in imbalance and dizziness.

    every 3-7 days for one month

Interventions

rehabilitation maneuverOTHER

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.

Also known as: rotatory maneuver

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of vertigo for at least one year
  • Not under drug therapy for vertigo
  • directional preponderance \>10% measured by electronystagmography during rotation test

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestibular and auditory center of Day General Hospital

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 30723455DERIVED

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nayer Rassaian, MD, PhD

    Shaheed Beheshti University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Doctor

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

November 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

IR(1)