Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Disease, Inner Ear Injury
Conditions
Brief summary
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.
Interventions
DEVICEVestibular retraining with dynamic posturography
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
BEHAVIORALAt-home rehabilitation exercises
6 weeks of daily rehabilitation exercises involving nodding and shaking of the head
Sponsors
Eytan A. David
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled interventional trial; single crossover; single-centre, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOT composite score | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function) |
| Dizziness Handicap Inventory | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOT condition scores | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) |
| LOS directional control | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function) |
| ABC Score | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function) |
| DHI component scores | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Emotional, physical, and functional components of the DHI score |
| SOT vestibular contribution | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | 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 |
| LOS excursion | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function) |
| FES-I score | Through study completion, 12 rehabilitation sessions, an average of 7 weeks | Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment |
Countries
Canada
Outcome results
None listed