Vibrotactile Feedback During Vestibular Therapy

February 5, 2018 updated by: Susan Whitney, University of Pittsburgh

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Vibrotactile Feedback
Balance training Vibrotactile feedback applied to the trunk
No Intervention: Without Vibrotactile Feedback
Balance training without feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sensory Organization Testing
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in 10-meter walk test
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Dynamic Gait Index and Functional Gait Assessment
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Measures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled.
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Five Times Sit to Stand
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
A stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Activities-specific Balance Confidence Scale
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
A 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living.
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Dizziness Handicap Inventory
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Short Form-12
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
A 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

University of Michigan
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13020399
  • 5R21DC012410 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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