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Clinical Trials/NCT02867683
NCT02867683
Completed
N/A

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

University of Pittsburgh1 site in 1 country27 target enrollmentOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vestibular Disease
Sponsor
University of Pittsburgh
Enrollment
27
Locations
1
Primary Endpoint
Change in Five Times Sit to Stand
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
January 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Whitney

Professor

University of Pittsburgh

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

Outcomes

Primary Outcomes

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

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.

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.

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.

Secondary Outcomes

  • Change in Activities-specific Balance Confidence Scale(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)
  • Change in Short Form-12(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)
  • Change in Dizziness Handicap Inventory(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)

Study Sites (1)

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