Cerebrovascular AccidentNCT00567944
Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke
A study testing BrainPort Balance Device in people with Cerebrovascular Accident, run by Wicab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- BrainPort Balance Device
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Middleton, Wisconsin, 53562
About this study
Official title: A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- BrainPort Balance Device
- Keywords
- Physical Therapy Modalities, Electric Stimulation, Postural Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPort Balance DeviceDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
Measured: baseline, 5 days, end of study
Berg Balance Scale
Measured: Baseline, 5 days, end of study
Activities-specific Balance Confidence Scale
Measured: Baseline, 5 days, end of study
Timed Up and Go
Measured: Baseline, 5 days, end of study
Stroke Impact Scale
Measured: Baseline, 5 day, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Beth Badke, PT, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567944
- Sponsor's protocol ID
- WCB4-001
- Status last verified
- Jun 2012
- First submitted
- 3 Dec 2007
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14643370Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
PubMed 15988797Tyler 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.
PubMed 15011268Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
PubMed 16385646
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke
- ClinicalTrials.gov ID
- NCT00567944
- Acronym / sponsor ID
- WCB4-001
- Conditions
- Cerebrovascular Accident
- Keywords
- Physical Therapy Modalities, Electric Stimulation, Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainPort Balance DeviceThe BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue. | Device | – |
Primary outcome
Dynamic Gait Index
Time frame: baseline, 5 days, end of study
Berg Balance Scale
Time frame: Baseline, 5 days, end of study
Activities-specific Balance Confidence Scale
Time frame: Baseline, 5 days, end of study
Timed Up and Go
Time frame: Baseline, 5 days, end of study
Stroke Impact Scale
Time frame: Baseline, 5 day, end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Background: PubMed 14643370Bach-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.
- Background: PubMed 15988797Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
- Background: PubMed 15011268Tyler 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.
- Background: PubMed 16385646Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
- Wicab Inc. homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Beth Badke, PT, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainPort Balance Device in people with Cerebrovascular Accident, run by Wicab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: baseline, 5 days, end of study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00567944, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.