Clinical trial NCT00567944: Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke
Official title: A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Physical Therapy Modalities
Electric Stimulation
Postural Balance
Lead sponsor: Wicab
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: baseline, 5 days, end of study
measure: Berg Balance Scale
timeFrame: Baseline, 5 days, end of study
measure: Activities-specific Balance Confidence Scale
timeFrame: Baseline, 5 days, end of study
measure: Timed Up and Go
timeFrame: Baseline, 5 days, end of study
measure: Stroke Impact Scale
timeFrame: Baseline, 5 day, end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Middleton
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mary Beth Badke, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6. doi: 10.1016/j.tics.2003.10.013.
citation: Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
citation: 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. doi: 10.1142/s0219635203000263.
citation: Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.