Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

ClinicalTrials.gov Identifier:

NCT00032383

First received: March 20, 2002

Last updated: January 19, 2007

Last verified: July 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2002
Last Updated Date	January 19, 2007
Start Date ^ICMJE	April 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00032383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System
Official Title ^ICMJE	Complementary/Alternative Medicine for Vestibulopathy
Brief Summary	The purpose of this study is to determine the relative merits of vestibular rehabilitation and Tai Chi for patients with inner ear (vestibular) disorders.
Detailed Description	It is proposed a randomized, blinded, controlled trial comparing vestibular rehabilitation (VR) to Tai Chi (TC). Our overall goal is to explore whether, and if so, how TC can improve functional, dynamic stability in persons with vestibulopathy (VSP). It is hypothesized that the TC group will demonstrate significantly greater improvement in performing functional activities than the VR group. Sixty subjects will be randomly assigned into either TC instruction or VR. Both treatment groups will receive identical duration treatment once a week for 10 weeks, with supplemental home exercises. It is hypothesized that 1) TC improves whole-body dynamic locomotor stability more than does VR; 2) TC improves gait coordination during planned and unplanned obstacle encounters more than does VR; 3) TC improves whole-body speed related movement control more than does VR.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Vestibular Neuronitis Vestibulopathy
Intervention ^ICMJE	Behavioral: Tai Chi
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Estimated Completion Date	April 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Main inclusion criteria: vestibulopathy and locomotor unsteadiness Main exclusion criteria: diseases/impairments that prevent rehab participation.
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00032383
Other Study ID Numbers ^ICMJE	R21AT000553-01
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Center for Complementary and Integrative Health (NCCIH)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Complementary and Integrative Health (NCCIH)
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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