Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System
Primary Purpose
Vestibular Neuronitis, Vestibulopathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Neuronitis focused on measuring Rehabilitation, Tai Chi
Eligibility Criteria
Main inclusion criteria: vestibulopathy and locomotor unsteadiness Main exclusion criteria: diseases/impairments that prevent rehab participation.
Sites / Locations
- Massachusetts General Hospital Biomotion Laboratory
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032383
First Posted
March 20, 2002
Last Updated
January 19, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00032383
Brief Title
Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System
Official Title
Complementary/Alternative Medicine for Vestibulopathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuronitis, Vestibulopathy
Keywords
Rehabilitation, Tai Chi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria:
vestibulopathy and locomotor unsteadiness
Main exclusion criteria:
diseases/impairments that prevent rehab participation.
Facility Information:
Facility Name
Massachusetts General Hospital Biomotion Laboratory
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.massgeneral.org/departments.html
Description
Click here to visit the Massachusetts General Hospital.
Learn more about this trial
Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System
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