Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke - Full Text View

Sponsor:	Wicab
Information provided by:	Wicab
ClinicalTrials.gov Identifier:	NCT00567944

Purpose

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
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

Further study details as provided by Wicab:

Primary Outcome Measures:

Dynamic Gait Index [ Time Frame: baseline, 5 days, end of study ] [ Designated as safety issue: No ]
Berg Balance Scale [ Time Frame: Baseline, 5 days, end of study ] [ Designated as safety issue: No ]
Activities-specific Balance Confidence Scale [ Time Frame: Baseline, 5 days, end of study ] [ Designated as safety issue: No ]
Timed Up and Go [ Time Frame: Baseline, 5 days, end of study ] [ Designated as safety issue: No ]
Stroke Impact Scale [ Time Frame: Baseline, 5 day, end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567944

Locations

United States, Wisconsin
University of Wisconsin-Madison
Middleton, Wisconsin, United States, 53562

Sponsors and Collaborators

Wicab

Investigators

Principal Investigator:

Mary Beth Badke, PT, PhD

University of Wisconsin, Madison

More Information

Additional Information:

Wicab Inc. homepage This link exits the ClinicalTrials.gov site

Publications:

Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6.

Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. Review.

Tyler M, Danilov Y, Bach-Y-Rita P. Closing an open-loop control system: vestibular substitution through the tongue. J Integr Neurosci. 2003 Dec;2(2):159-64.

Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. Review.

Responsible Party:	Wicab, Inc. ( Carrie Nemke, MPT )
Study ID Numbers:	WCB4-001
Study First Received:	December 3, 2007
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00567944 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Wicab:

Physical Therapy Modalities
Electric Stimulation
Postural Balance

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010