Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness

People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.

Study Overview

• Status: Completed
• Conditions: Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Injury
• Intervention / Treatment: Device: Vestibular rehabilitation with dynamic posturography

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7M 2H5
      • Dr. EA David MD FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult Age 18-80

• Unilateral vestibular weakness confirmed one or more of:

  • Videonystagmography
  • VEMP
• Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
• Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
• Symptomatic
• Long-standing/persistent symptoms greater than one year

Exclusion Criteria:

• Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
• Neurological deficit or proprioception deficit
• Diabetes
• Poor vision or blindness
• Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal deshicsence (SDCS)
• Active benign paroxysmal positional vertigo (BPPV)
• Undergoing treatment which may affect balance or ability to stand
• Cognitive impairment that prevents understanding and responding to instructions required to complete the study
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vestibular rehabilitation with dynamic posturography; 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback	Device: Vestibular rehabilitation with dynamic posturography; Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)	Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual; Eyes open on sway referenced support surface; Eyes close on sway referenced support surfrace; Eyes open on sway referenced support surface and visual	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)	Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)	Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)	Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)	Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)	Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) The 6 conditions are: Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual; Eyes open on sway referenced support surface; Eyes close on sway referenced support surfrace; Eyes open on sway referenced support surface and visual	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)	Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)	Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)	Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Rehabilitation Protocol	Percentage of subjects that complete 12 sessions	Through study completion, maximum of 12 weeks
Missed Sessions	Mean number of missed and rescheduled rehabilitation sessions	Through study completion, maximum of 12 weeks

Collaborators and Investigators

• Sponsor: Eytan A. David
• Investigators: Principal Investigator: Eytan David, MD, University of British Columbia

Publications and helpful links

General Publications

• David EA, Shahnaz N. Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):426-433. doi: 10.1001/jamaoto.2022.0167.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Dizziness
• Other Study ID Numbers: H20-04045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes