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Completed

NCT Number: NCT02867683

Vibrotactile Feedback During Vestibular Therapy

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.

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Key information

Conditions

Vestibular Disease Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrotactile feedback

Other

Balance training Vibrotactile feedback applied to the trunk

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Aug 16, 2016
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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