Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

Study Overview
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Brief Summary
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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.

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

Conditions
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Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury, Inner Ear Disease

Intervention / Treatment
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* Device: Vestibular retraining with dynamic posturography
* Behavioral: At-home rehabilitation exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled interventional trial; single crossover; single-centre, open label
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |