NCT00567944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

December 3, 2007

Last Update Submit

June 27, 2012

Conditions

Cerebrovascular Accident

Keywords

Physical Therapy ModalitiesElectric StimulationPostural Balance

Outcome Measures

Primary Outcomes (5)

  • Dynamic Gait Index

    baseline, 5 days, end of study

  • Berg Balance Scale

    Baseline, 5 days, end of study

  • Activities-specific Balance Confidence Scale

    Baseline, 5 days, end of study

  • Timed Up and Go

    Baseline, 5 days, end of study

  • Stroke Impact Scale

    Baseline, 5 day, end of study

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Middleton, Wisconsin, 53562, United States

Location

Related Publications (4)

  • 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.

    PMID: 14643370BACKGROUND

  • Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.

    PMID: 15988797BACKGROUND

  • 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.

    PMID: 15011268BACKGROUND

  • Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.

    PMID: 16385646BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mary Beth Badke, PT, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(1)