Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainPort Balance Device
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Physical Therapy Modalities, Electric Stimulation, Postural Balance
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.
Sites / Locations
- University of Wisconsin-Madison
Outcomes
Primary Outcome Measures
Dynamic Gait Index
Berg Balance Scale
Activities-specific Balance Confidence Scale
Timed Up and Go
Stroke Impact Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567944
Brief Title
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
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wicab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Physical Therapy Modalities, Electric Stimulation, Postural Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
BrainPort Balance Device
Intervention Description
The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Time Frame
baseline, 5 days, end of study
Title
Berg Balance Scale
Time Frame
Baseline, 5 days, end of study
Title
Activities-specific Balance Confidence Scale
Time Frame
Baseline, 5 days, end of study
Title
Timed Up and Go
Time Frame
Baseline, 5 days, end of study
Title
Stroke Impact Scale
Time Frame
Baseline, 5 day, end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Badke, PT, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14643370
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.
Results Reference
background
PubMed Identifier
15988797
Citation
Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
Results Reference
background
PubMed Identifier
15011268
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.
Results Reference
background
PubMed Identifier
16385646
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.
Results Reference
background
Links:
URL
http://www.wicab.com
Description
Wicab Inc. homepage
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Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke
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