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Vibrotactile Feedback During Vestibular Therapy

Primary Purpose

Vestibular Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrotactile Feedback
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disease focused on measuring vibrotactile feedback, vestibular rehabilitation, balance

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vibrotactile Feedback

Without Vibrotactile Feedback

Arm Description

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.

Balance training without feedback

Outcomes

Primary Outcome Measures

Change in Sensory Organization Testing
Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Change in 10-meter walk test
Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Change in Dynamic Gait Index and Functional Gait Assessment
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.
Change in Five Times Sit to Stand
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

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

Full Information

First Posted
August 4, 2016
Last Updated
February 5, 2018
Sponsor
University of Pittsburgh
Collaborators
University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02867683
Brief Title
Vibrotactile Feedback During Vestibular Therapy
Official Title
The Effects of Vibrotactile Feedback During Vestibular Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disease
Keywords
vibrotactile feedback, vestibular rehabilitation, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibrotactile Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Without Vibrotactile Feedback
Arm Type
No Intervention
Arm Description
Balance training without feedback
Intervention Type
Other
Intervention Name(s)
Vibrotactile Feedback
Intervention Description
Balance training Vibrotactile feedback applied to the trunk
Primary Outcome Measure Information:
Title
Change in Sensory Organization Testing
Description
Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Title
Change in 10-meter walk test
Description
Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Title
Change in Dynamic Gait Index and Functional Gait Assessment
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Title
Change in Five Times Sit to Stand
Description
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
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Secondary Outcome Measure Information:
Title
Change in Activities-specific Balance Confidence Scale
Description
A 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living.
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Title
Change in Dizziness Handicap Inventory
Description
A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Title
Change in Short Form-12
Description
A 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life
Time Frame
Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vibrotactile Feedback During Vestibular Therapy

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