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Sponsored by: |
Wicab |
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Information provided by: | Wicab |
ClinicalTrials.gov Identifier: | NCT00768378 |
The purpose of this study is to assess the safety and efficacy of the BrainPort balance device in improving balance and gait as measured by clinically accepted standardized balance assessments in subjects with peripheral vestibular dysfunction.
Condition | Intervention |
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Vestibular Diseases Gait Disorders |
Device: Training with the BrainPort balance device |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Clinical Study to Evaluate the Safety and Efficacy of the BrainPort® Balance Device When Used to Improve Balance in Subjects With Peripheral Vestibular Dysfunction |
Estimated Enrollment: | 242 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Perceived stimulation: Experimental
When subjects assigned to the perceived stimulation group increase the intensity of the stimulus, they will feel a tingling sensation on the tongue. The tingling will move on the tongue in relation to where the head/body moves. |
Device: Training with the BrainPort balance device
Subjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other.
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Subliminal stimulation: Experimental
When subjects assigned to the subliminal stimulation group increase the intensity of the stimulus, the device provides a stimulus that is below their conscious awareness, so they will not be able to perceive it. The stimulus will move on the tongue in relation to where the head/body moves.
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Device: Training with the BrainPort balance device
Subjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other.
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Peripheral vestibular dysfunction can be caused by inner ear disorders, drug toxicity, neuritis, or a number of other causes. In the absence of a fully functional vestibular system, the brain often requires retraining to correctly utilize visual and proprioceptive cues to maintain postural stability.
People with vestibular dysfunction experience multiple problems with posture control and movement, including an unsteady gait and various balance-related difficulties. These effects make it very difficult to walk in the dark or on uneven surfaces without risk of falling. They are typically referred for conventional vestibular therapy. Many patients improve with therapeutic intervention. Some patients reach a plateau and do not return to their previous level of function. The BrainPort balance device transmits head position information via electrotactile stimulation of the tongue. With training, patients learn to use the positional information to correct their balance.
Participants meeting the study criteria will be randomized to the perceived stimulation or subliminal stimulation group. All participants will be given baseline assessments of postural stability, balance, and subjective well being according to standardized tests. After completing the baseline assessments, each participant will be trained in the clinic using a standard training protocol with the BrainPort balance device. Each participant will participate in 6 clinical training sessions, over a period of 3 consecutive days. Upon completion of the clinic training sessions, participants will continue with a 7½ week period of home use. During this period, the participant will train with the device for 20 minutes 2 times per day and the clinicians will contact the participants weekly. At the end of the home training period (8 weeks from the beginning of the study), all participants will again undergo the tests given at baseline.
Following the data analysis, subjects that have completed the 8 week study and were originally assigned to the group with inferior results will be given the opportunity to use the device that showed superior results in the data analysis.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
Functional Ability:
Exclusion Criteria:
Current diagnosis of any of the following:
Contact: Kevin Siewert | 608-829-4513 | ksiewert@wicab.com |
United States, California | |
England Physical Therapy | Recruiting |
Los Angeles, California, United States, 92840 | |
Contact: Teresa England, MPT 714-703-8477 teresapt@msn.com | |
Principal Investigator: Teresa England, MPT | |
United States, Florida | |
Sensory Therapeutics, Inc. | Recruiting |
Jupiter, Florida, United States, 33458 | |
Contact: Rose Ann Curboy, MS, OTR/L 561-745-0028 sensorytherapeut@bellsouth.net | |
Principal Investigator: John Li, MD, FACS | |
United States, Georgia | |
Atlanta Ear Clinic | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Gaye Cronin, OTR 404-851-9093 earclinic@mindspring.com | |
Principal Investigator: Ron Steenerson, MD | |
Medical College of Georgia | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Lisa Barnhill 706-721-7376 lbarnhill@mail.mcg.edu | |
Principal Investigator: Brian McKinnon, MD | |
United States, Missouri | |
Missouri State University | Recruiting |
Springfield, Missouri, United States, 65897 | |
Contact: Susan Robinson, PT, DPT 417-836-6013 susanrobinson@missouristate.edu | |
Principal Investigator: Susan Robinson, PT, DPT | |
United States, New York | |
New York Eye and Ear Infirmary | Recruiting |
New York, New York, United States, 10010 | |
Contact: Laura Lei Rivera, PT 646-438-7804 llei@nyee.edu | |
Contact: Anu Abraham, PT 646-438-7804 aabraham@nyee.edu | |
Principal Investigator: Ana Kim, MD | |
United States, Oregon | |
Progressive Rehab Associates | Recruiting |
Portland, Oregon, United States, 97225 | |
Contact: Kathy De Domingo 503-292-0765 Kathy@progrehab.com | |
Principal Investigator: Kevi Ames, PT | |
United States, Texas | |
360 Balance Therapy of Texas | Recruiting |
Austin, Texas, United States, 78757 | |
Contact: Bridgett Wallace, PT 512-345-4664 ext 100 bridgett@360balance.com | |
Principal Investigator: Bridgett Wallace, PT | |
Austin ENT Clinic | Recruiting |
Austin, Texas, United States, 78705 | |
Contact: Tammi Schreiner, LVN 512-323-2432 tschreiner@austinent.com | |
Principal Investigator: John R McFarlane, Sr., MD | |
United States, Virginia | |
Eastern Virginia Medical School | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Pamela Kennedy, RN, BSN, OCN 757-388-6238 kennedpw@evms.edu | |
Principal Investigator: Barry Strasnick, MD | |
United States, Washington | |
Pacific Balance and Rehabilitation Clinic | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Julie Grove, PT 206-448-1906 jgrove@pbrcseattle.com | |
Principal Investigator: Julie Grove, PT | |
University of Washington School of Medicine | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Olena Velushchak 206-221-0704 olena@u.washington.edu | |
Principal Investigator: James Phillips, MD | |
United States, Wisconsin | |
Aurora St. Luke's Medical Center | Recruiting |
Milwaukee, Wisconsin, United States, 53215 | |
Contact: Phyllis Runningen, RN, BSN 414-385-2712 phyllis.runningen@aurora.org | |
Principal Investigator: Scott Hardin, MD | |
Aurora BayCare Medical Center | Recruiting |
Green Bay, Wisconsin, United States, 54308 | |
Contact: Bridget Kulick, PT 920-288-4709 bridget.kulick@aurorabaycare.com | |
Principal Investigator: Bridget Kulick, PT |
Principal Investigator: | James O. Phillips, PhD | University of Washington |
Responsible Party: | Wicab, Inc. ( Kim Skinner, MPT ) |
Study ID Numbers: | WCB1-005, NIH: 2R44 DC004738 |
Study First Received: | October 6, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00768378 History of Changes |
Health Authority: | United States: Institutional Review Board |
Physical Therapy (Specialty) Balance dysfunction or disorder Vestibular Rehabilitation |
Otorhinolaryngologic Diseases Vestibular Diseases Ear Diseases |
Otorhinolaryngologic Diseases Vestibular Diseases Ear Diseases Labyrinth Diseases |