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Vibrotactile Feedback During Vestibular Therapy

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ClinicalTrials.gov Identifier: NCT02867683
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
University of Michigan
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Susan Whitney, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vestibular Disease Other: Vibrotactile Feedback Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vibrotactile Feedback During Vestibular Rehabilitation
Study Start Date : October 2013
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : January 31, 2018

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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867683


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
University of Michigan
National Institute on Deafness and Other Communication Disorders (NIDCD)

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Responsible Party: Susan Whitney, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02867683     History of Changes
Other Study ID Numbers: PRO13020399
5R21DC012410 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Susan Whitney, University of Pittsburgh:
vibrotactile feedback
vestibular rehabilitation
balance

Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases