Virtual Environments for Vestibular Rehabilitation
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|ClinicalTrials.gov Identifier: NCT04268745|
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : May 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Dizziness Chronic Vertigo, Peripheral Fall||Behavioral: Balance training Behavioral: Traditional Vestibular Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Vestibular Rehabilitation Utilizing Virtual Environments to Train Sensory Integration for Postural Control in a Functional Context|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Virtual Reality
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Behavioral: Balance training
Progressive balance training within virtual environments
Active Comparator: Traditional Vestibular Rehabilitation
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Behavioral: Traditional Vestibular Rehabilitation
Progressive balance training and gaze stability exercises
- Visual Vertigo Analog Scale (VVAS) [ Time Frame: 8 weeks ]The Visual Vertigo Analogue Scale (VVAS) is a self-reported questionnaire where a participant rates their visual vertigo on a 10 cm line in 9 different visually challenging environments. A score of 0 indicates no dizziness. Maximal score is 100 (calculated as the measurement on each item X 9 divided by 10).
- Functional Gait Analysis (FGA) [ Time Frame: 8 weeks ]A functional test designed to assess individual's ability to perform various motor tasks, such as: walking with eyes closed, walking backwards, climbing stairs. There are 10 items, each is scored by a therapist on a scale of 0 (severe impairment) to 3 (normal). Maximal score is 30. Higher is better.
- Power Spectral Density [ Time Frame: 8 weeks ]The postural sway signal (derived from a force platform) is decomposed into its frequency components. This technique allows for quantifying overall variability of COP sway (COP variance = sum of power at all frequency components) as well as specific components associated with pathological and/or physiological balance control. In our paradigm, PSD 1 (0.05 to 0.25 Hz) includes the visual frequency and will indicate visual weighting. PSD 2 (0.25 to 0.5 Hz) includes the auditory frequency and will indicate auditory weighting. PSD 3 (0.5 to 1 Hz) will indicate small corrective adjustments, and overall PSD will indicate destabilization induced by the stimulus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268745
|Contact: Anat Lubetzky, PhDfirstname.lastname@example.org|
|Contact: Jennifer Kelly, DPT||646-438-7868||JKelly@nyee.edu|
|United States, New York|
|New York Eye and Ear Infirmary of Mount Sinai||Recruiting|
|New York, New York, United States, 10010|
|Contact: Jennifer Kelly, DPT 646-438-7868 JKelly@nyee.edu|
|Contact: Bryan Hujsak, DPT 6464387861 email@example.com|
|New York University Physical Therapy Department||Recruiting|
|New York, New York, United States, 10010|
|Contact: Anat Lubetzky, PhD 212-998-9195 firstname.lastname@example.org|
|Contact: John Sutera, DPT email@example.com|
|Principal Investigator:||Anat Lubetzky, PhD||New York University|