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Completed

NCT Number: NCT00889824

Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.

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Key information

Conditions

Dizziness Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the "development of assistive devices for balance disorders". The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.

Exclusion criteria

  • Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
  • Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
  • Peripheral neuropathies of the lower extremities.
  • 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.

Treatment and study plan

balance prosthesis

Device

vibrotactile stimulation

Primary outcomes

  1. Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.

    Time frame: 6 weeks

    The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Barron Associates, Inc.
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2009
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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