Effects of a Vestibular Rehabilitation Maneuver
| Tracking Information | |||||
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| First Received Date ICMJE | March 3, 2010 | ||||
| Last Updated Date | March 3, 2010 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Directional preponderance [ Time Frame: Every 3-7 days for one month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
subjective sense of a decrease in vertigo on a scale of 1-10 [ Time Frame: every 3-7 days for one month ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a Vestibular Rehabilitation Maneuver | ||||
| Official Title ICMJE | Short-term and Long-term Effects of the Rotational Maneuver in Patients With Chronic Vestibular Imbalance | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Vertigo | ||||
| Intervention ICMJE | 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.
Other Name: rotatory maneuver |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01080430 | ||||
| Other Study ID Numbers ICMJE | DGH-VR02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Nayer Rassaian, Shaheed Beheshti University of Medical Sciences | ||||
| Study Sponsor ICMJE | Day General Hospital. | ||||
| Collaborators ICMJE | Shaheed Beheshti Medical University | ||||
| Investigators ICMJE |
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| Information Provided By | Day General Hospital. | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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