Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit

People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.

Study Overview

• Status: Active, not recruiting
• Conditions: Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Injury; Inner Ear Disease
• Intervention / Treatment: Device: Vestibular retraining with dynamic posturography; Behavioral: At-home rehabilitation exercises

• Study Type: Interventional
• Enrollment (Actual): 37
• 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: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Dizziness handicap inventory score at time of enrolment over 30

• Unilateral vestibular weakness confirmed one or more of:

  • Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
  • VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
  • VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
  • 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 six months

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 dehiscence (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: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vestibular retraining with dynamic posturography; 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback	Device: Vestibular retraining with dynamic posturography; 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Active Comparator: At-home rehabilitation exercises; Daily rehabilitation exercises involving nodding and shaking of the head	Behavioral: At-home rehabilitation exercises; 6 weeks of daily rehabilitation exercises involving nodding and shaking of the head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOT composite score	Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Dizziness Handicap Inventory	Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABC Score	Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
FES-I score	Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT condition scores	Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
LOS directional control	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
LOS excursion	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
DHI component scores	Emotional, physical, and functional components of the DHI score	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT vestibular contribution	Change in mean value of SOT 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Otorhinolaryngologic Diseases; Sensation Disorders; Otitis; Dizziness; Ear Diseases; Labyrinthitis; Labyrinth Diseases
• Other Study ID Numbers: H21-03343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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