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Sponsored by: |
Wicab |
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Information provided by: | Wicab |
ClinicalTrials.gov Identifier: | NCT00567944 |
The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke.
Condition | Intervention |
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Cerebrovascular Accident |
Device: BrainPort Balance Device |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing at the end of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kim Skinner, MPT | 608-829-4515 | kskinner@wicab.com |
Contact: Carrie Nemke, MPT | 608-829-4512 | cnemke@wicab.com |
United States, Indiana | |
Rehabilitation Hospital of Indiana | Completed |
Indianapolis, Indiana, United States, 46268 | |
United States, Kansas | |
University of Kansas Medical Center | Completed |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
Physical Therapy Center of Horseheads | Completed |
Horseheads, New York, United States, 14845 | |
United States, Wisconsin | |
University of Wisconsin-Madison | Recruiting |
Middleton, Wisconsin, United States, 53562 | |
Contact: Mary Beth Badke, PT, PhD 608-263-8088 mb.badke@hosp.wisc.edu | |
Principal Investigator: Mary Beth Badke, PT, PhD | |
Principal Investigator: Jack Sherman, PhD | |
Principal Investigator: Steven Deutsch, MD |
Study Director: | Monica Metea, PhD | Wicab, Inc |
Responsible Party: | Wicab, Inc. Physical Therapy Manager ( Kim Skinner, MPT ) |
Study ID Numbers: | WCB4-001 |
Study First Received: | December 3, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00567944 |
Health Authority: | United States: Institutional Review Board |
Physical Therapy Modalities Electric Stimulation Postural Balance |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |