Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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 after using the device at home for 7 weeks.

Official Title
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A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: BrainPort Balance Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old. Diagnosis of stroke for at least 6 months. Reached a plateau and been discharged from physical therapy. Able to ambulate with or without assistance. Ongoing balance problem. Able to read and understand the informed consent form, and willing to sign the informed consent form. 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. History of seizures. Pregnancy. Cognitive deficits (Mini-Mental 25 or below), joint replacements, cervical vertigo, or major neurologic disease, major depression or disabling psychiatric disorder. Known neuropathies of tongue or skin tactile system. Prior exposure to BrainPort® balance device. 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. Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani nerve, lingual nerve, or hypoglossal nerve.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BrainPort Balance Device|The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Gait Index |  | baseline, 5 days, end of study | 
| Berg Balance Scale |  | Baseline, 5 days, end of study | 
| Activities-specific Balance Confidence Scale |  | Baseline, 5 days, end of study | 
| Timed Up and Go |  | Baseline, 5 days, end of study | 
| Stroke Impact Scale |  | Baseline, 5 day, end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Therapy Modalities, Electric Stimulation, Postural Balance