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

Completed · Not applicable

Conditions studied: Cerebrovascular Accident

In brief

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.

Key facts

Study ID: NCT00567944
Run by: Wicab
People needed: 29
Starts: 2007-06-01
Expected to finish: 2010-04-01
Last updated by the study team: 2012-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Wisconsin-Madison — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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