Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dizziness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prosthesis group

balance prosthesis

Group Type EXPERIMENTAL

balance prosthesis

Intervention Type DEVICE

vibrotactile stimulation

Interventions

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balance prosthesis

vibrotactile stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No