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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

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Physical Therapy Modalities, Electric Stimulation, Postural Balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00567944

First Posted

December 3, 2007

Last Updated

June 27, 2012

Sponsor

Wicab

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

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

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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