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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567944
First Posted: December 5, 2007
Last Update Posted: June 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wicab
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]
  • 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 ]

Enrollment: 29
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: April 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: Wicab
ClinicalTrials.gov Identifier: NCT00567944     History of Changes
Other Study ID Numbers: WCB4-001
First Submitted: December 3, 2007
First Posted: December 5, 2007
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Wicab:
Physical Therapy Modalities
Electric Stimulation
Postural Balance

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases