Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

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

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-07-31

Brief Summary

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Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.

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Detailed Description

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Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS) and ten healthy age and gender matched subjects will be asked to perform tests involving walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that will be worn under the clothes around the subjects waist and uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and motion.

Conditions

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Dizziness Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Subjective Dizziness Syndrome Subjects

Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.

Group Type EXPERIMENTAL

Balance Belt

Intervention Type DEVICE

Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait

Healthy Subjects

Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.

Group Type ACTIVE_COMPARATOR

Balance Belt

Intervention Type DEVICE

Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait

Interventions

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Balance Belt

Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait

Intervention Type DEVICE

Other Intervention Names

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Stabalon Belt Vibrating Belt

Eligibility Criteria

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Inclusion Criteria

* Subjects will be 25-70 years of age inclusive and pregnant women may participate.
* Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry \& Psychology.
* Normal volunteers will have a negative history of otologic \& neurologic disorders and no history of dizziness and balance problems.
* Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.

Exclusion Criteria

* Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone.
* Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials.
* Subjects with hearing impairment that interferes with oral communication.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes