Vibrotactile Feedback During Vestibular Therapy

NCT02867683 | Completed

• 2 other identifiers: PRO130203995R21DC012410
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disease

Keywords

vibrotactile feedback; vestibular rehabilitation; balance

Outcome Measures

Primary Outcomes (4)

• Change in Sensory Organization Testing

  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

  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

  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

  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 Outcomes (3)

• Change in Activities-specific Balance Confidence Scale

  Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

• Change in Dizziness Handicap Inventory

  Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

• Change in Short Form-12

  Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Study Arms (2)

Vibrotactile Feedback

EXPERIMENTAL

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

Without Vibrotactile Feedback

NO INTERVENTION

Balance training without feedback

Interventions

Vibrotactile Feedback OTHER

Balance training Vibrotactile feedback applied to the trunk

Vibrotactile Feedback

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral peripheral vestibular hypofunction
• bilateral peripheral vestibular hypofunction

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Michigan: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 16, 2016
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: January 31, 2018
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

US (1)