Vibrotactile Feedback During Vestibular Therapy

Vestibular Disease Clinical Trial

Official title:

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867683
• Other study ID #: PRO13020399
• Secondary ID: 5R21DC012410
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: February 5, 2018
• Start date: October 2013
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 31, 2018
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Disease
• Vestibular Diseases

Intervention

Other:
• Vibrotactile Feedback
Balance training Vibrotactile feedback applied to the trunk

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Secondary	Change in Dizziness Handicap Inventory	A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.	Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Secondary	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	Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks