Vibrotactile Feedback During Vestibular Therapy

NCT ID: NCT02867683

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-01-31

Brief Summary

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This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.

Detailed Description

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Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result.

Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.

Conditions

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Vestibular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vibrotactile Feedback

Balance exercises completed while vibration was applied to the trunk (anterior, posterior, right, and left) if postural sway exceeded a pre-determined threshold during the exercise.

Group Type EXPERIMENTAL

Vibrotactile Feedback

Intervention Type OTHER

Balance training Vibrotactile feedback applied to the trunk

Without Vibrotactile Feedback

Balance training without feedback

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vibrotactile Feedback

Balance training Vibrotactile feedback applied to the trunk

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* unilateral peripheral vestibular hypofunction
* bilateral peripheral vestibular hypofunction

Exclusion Criteria

* confounding neurologic or neuromuscular disorders
* pregnancy
* inability to stand for 3 minutes
* recent lower extremity fracture/severe sprain within the last 6 months
* previous lower extremity joint replacement
* incapacitating back or lower extremity pain
* body too large for equipment
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Susan Whitney

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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5R21DC012410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO13020399

Identifier Type: -

Identifier Source: org_study_id

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