Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Environments for Vestibular Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268745
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
New York University

Brief 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.


Condition or disease Intervention/treatment Phase
Dizziness Chronic Vertigo, Peripheral Fall Behavioral: Balance training Behavioral: Traditional Vestibular Rehabilitation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Virtual reality
  • Contextual sensory integration training
  • HTC Vive

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




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anat Lubetzky, PhD 212-998-9195 anat@nyu.edu
Contact: Jennifer Kelly, DPT 646-438-7868 JKelly@nyee.edu

Locations
Layout table for location information
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    bhujsak@nyee.edu   
New York University Physical Therapy Department Recruiting
New York, New York, United States, 10010
Contact: Anat Lubetzky, PhD    212-998-9195    anat@nyu.edu   
Contact: John Sutera, DPT       js815@nyu.edu   
Sponsors and Collaborators
New York University
Icahn School of Medicine at Mount Sinai
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Anat Lubetzky, PhD New York University

Layout table for additonal information
Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT04268745    
Other Study ID Numbers: 19-02-223
5P2CHD086851-05 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders