N/A
N=13
Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness
Dizziness · Equilibrium; Disorder, Labyrinth · Inner Ear Injury
Bottom Line
View on ClinicalTrials.gov: NCT04875013 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline) — 8.8 SOT composite score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vestibular rehabilitation with dynamic posturography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eytan A. David
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline) |
8.8 | — |
| PRIMARY Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline) |
-16 | — |
| PRIMARY Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline) |
11.87 | — |
| PRIMARY Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline) |
-9 | — |
| PRIMARY Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline) |
6226; 9802 | — |
| SECONDARY Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) |
0.6; -1.8; -1.6; 13.9; 11.1; 13.1 | — |
| SECONDARY Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline) |
0.10 | — |
| SECONDARY Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline) |
41.1 | — |
| SECONDARY Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline) |
36; 47 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04875013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.