Substitute Vestibular Information System Using the BrainPort Balance Device for Adults with Chronic Vestibular Dysfunction Following Stroke or Traumatic Brain Injury
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Status:
Ongoing. Currently enrolling patients.
Purpose:
To evaluate the safety and effectiveness of the BrainPort balance device in treating patients with balance deficits following a stroke or traumatic brain injury.
Interventions:
BrainPort Balance Device
a non-invasive medical device that provides head and body position information to a person via their tongue.
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Location(s):
Indiana, Kansas, New York, Wisconsin
Year Started:
2007
Year Presented:
2009
Design:
Interventional, Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Inclusion Criteria
Diagnosis of a stroke or brain injury at least 3 months ago; reached a plateau and been discharged from physical therapy; no current oral health problems; current balance problem; able to ambulate with or without assistance.
Exclusion Criteria
Current oral health problems as determined by health questionnaire and an examination of the oral cavity; any medical condition that would interfere with performance on the assessments; known neuropathies of tongue or skin tactile system; prior exposure to BrainPort® balance device; history of seizures; subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
Patient Involvement:
Patients will participate in BrainPort training sessions for 2 1-hour sessions with a Physical Therapist daily for 5 consecutive days in the clinic and will afterwards continue training for 2-20 minute sessions each day at home for 7 weeks. Assessments completed at baseline, 5 days and at end of study (8 weeks).
Primary Outcome:
Berg Balance Scale, Dynamic Gait Index, Stroke Impact Scale, Activities-specific Balance Confidence Scale, Timed Up and Go.
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Source of Information:
Correspondence with sponsor.
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/13/2009
Reviewed on: 05/22/2009.
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