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

Tracking Information
First Submitted Date ICMJE	March 20, 2002
First Posted Date ICMJE	March 22, 2002
Last Update Posted Date	January 22, 2007
Study 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; Primary Purpose: Treatment
Condition ICMJE	Vestibular Neuronitis; Vestibulopathy
Intervention ICMJE	Behavioral: Tai Chi
Study Arms	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; (submitted: June 23, 2005)	60
Original Enrollment ICMJE	Same as current
Study 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.
Sex/Gender	Sexes Eligible for Study: All
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( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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