N/A
N=30
Virtual Environments for Vestibular Rehabilitation
Dizziness Chronic · Vertigo, Peripheral · Fall
Bottom Line
View on ClinicalTrials.gov: NCT04268745 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Visual Vertigo Analog Scale (VVAS) — 43.05; 36.84; 31.28; 21.41 score on a scale — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Balance training (Behavioral); Traditional Vestibular Rehabilitation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Vertigo Analog Scale (VVAS) |
43.05; 36.84; 31.28; 21.41 | 0.027 sig |
| PRIMARY Functional Gait Analysis (FGA) |
20.43; 21.07; 26.35; 27.95 | 0.0001 sig |
| PRIMARY The Dizziness Handicap Inventory (DHI) |
53.07; 50.8 | 0.0002 sig |
| SECONDARY The Activities Balance Confidence Scale |
71.34; 74.21; 82.89; 79.78 | 0.028 sig |
| SECONDARY Timed-Up and Go |
7.97; 7.77; 7.93; 8.03 | 0.695 |
| SECONDARY The Four-Step Square Test |
11.49; 9.48; 10.29; 9.65 | 0.469 |
Summary
The specific aims of this pilot project are:
Aim #1: Determine the extent to which sensory integration strategies differ between 28 individuals with unilateral vestibular hypofunction and 28 age-matched peers. Participants' postural sway will be recorded as they experience two levels of moving stars10 and white noise, while standing on the floor or a compliant surface. Our working hypothesis is that patients with vestibular hypofunction utilize substitution strategies such that they will demonstrate greater visual and auditory reliance compared with controls, particularly when somatosensory cues are reduced via the support surface. We will then explore whether these mechanism changes after training.
Aim #2: Develop the protocol and establish the feasibility of a randomized controlled trial (RCT) comparing C.S.I. training to standard vestibular rehabilitation. Following the assessment, the 28 patients will be randomized into standard vestibular rehabilitation vs. C.S.I. training. This pilot study will enable us to test the feasibility of our recruitment, randomization procedures, establish attrition rate, and test the training protocol.
Aim #3: Generate pilot data for sample size calculation for a properly powered RCT. The follow up RCT will test the effect of C.S.I. training on: Visual Vertigo Analog Scale (VVAS), Functional Gait Analysis (primary); balance confidence, overall disability (descriptive). In our preliminary study, 8 patients met the inclusion criteria for the current proposal. Following the C.S.I. training, they had a large effect size of 1.17 on the VVAS. The current study will allow us to identify the between-group effect size for the VVAS and for a functional gait outcome.
Eligibility Criteria
Inclusion Criteria
- Adult patients (18 or older)
- Clinical diagnosis of chronic (3 months and longer) unilateral peripheral vestibular hypofunction
- Patients will be included based on the presence of a positive head thrust test, head shaking nystagmus, spontaneous nystagmus, and/or canal paresis > 25% if a caloric test is available.
- Included patients must present with at least two positive items on the VVAS
Exclusion Criteria
Patients will be excluded for prior vestibular rehab, bilateral or unstable vestibular loss or another neurological condition, active benign paroxysmal positional vertigo, acute orthopaedic injuries, peripheral neuropathy, hearing impairment, or visual impairment not corrected with glasses.
Data sourced from ClinicalTrials.gov (NCT04268745). 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.