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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:
Information provided by (Responsible Party):
Wicab
ClinicalTrials.gov Identifier:
NCT00567944
First received: December 3, 2007
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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

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:

Responsible Party: Wicab
ClinicalTrials.gov Identifier: NCT00567944     History of Changes
Other Study ID Numbers: WCB4-001
Study First Received: December 3, 2007
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013