Virtual Environments for Vestibular Rehabilitation
Completed · Not applicable
Conditions studied: Dizziness Chronic, Vertigo, Peripheral, Fall
In brief
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.
Key facts
- Study ID
- NCT04268745
- Run by
- New York University
- People needed
- 30
- Starts
- 2019-08-21
- Expected to finish
- 2022-05-23
- Last updated by the study team
- 2023-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States
- New York University Physical Therapy Department — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.