Virtual Environments for Vestibular Rehabilitation

NCT04268745 | Completed Results DMC

• 2 other identifiers: 19-02-2235P2CHD086851-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Dizziness Chronic; Vertigo, Peripheral; Fall

Outcome Measures

Primary Outcomes (3)

• Visual Vertigo Analog Scale (VVAS)

  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). A higher score indicates worse outcome.

  baseline and 8 weeks

• Functional Gait Analysis (FGA)

  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.

  baseline and 8 weeks

• The Dizziness Handicap Inventory (DHI)

  The DHI has 25 items and each item is scored as 'no', 'sometimes' or 'yes' to evaluate self-perceived disability imposed by dizziness. The minimum score is 0 and the maximum score is 100, a higher score indicates increased perceived disability. The scale is no = 0, sometimes = 2, and yes = 4.

  baseline and 8 weeks

Secondary Outcomes (3)

• The Activities Balance Confidence Scale

  baseline and 8 weeks

• Timed-Up and Go

  baseline and 8 weeks

• The Four-Step Square Test

  baseline and 8 weeks

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Traditional Vestibular Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Balance training BEHAVIORAL

Progressive balance training within virtual environments

Also known as: Virtual reality, Contextual sensory integration training, HTC Vive

Virtual Reality

Traditional Vestibular Rehabilitation BEHAVIORAL

Progressive balance training and gaze stability exercises

Traditional Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• New York University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10010, United States

Location

New York University Physical Therapy Department

New York, New York, 10010, United States

Location

Related Publications (2)

• Kelly J, Harel D, Krishnamoorthy S, Fu G, Morris B, Medlin A, Mischinati S, Wang Z, Sutera J, Perlin K, Cosetti M, Lubetzky AV. Contextual sensory integration training vs. traditional vestibular rehabilitation: a pilot randomized controlled trial. J Neuroeng Rehabil. 2023 Aug 12;20(1):104. doi: 10.1186/s12984-023-01224-6.

  PMID: 37568216 DERIVED

• Lubetzky AV, Harel D, Krishnamoorthy S, Fu G, Morris B, Medlin A, Wang Z, Perlin K, Roginska A, Cosetti M, Kelly J. Decrease in head sway as a measure of sensory integration following vestibular rehabilitation: A randomized controlled trial. J Vestib Res. 2023;33(3):213-226. doi: 10.3233/VES-220107.

  PMID: 36911951 DERIVED

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small pilot RCT; high dropout rate due to COVID 19 pandemic

Results Point of Contact

• Title: Dr. Anat Lubetzky
• Organization: New York University

anat@nyu.edu

2129989195

Study Officials

• Anat Lubetzky, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 13, 2020
• Study Start: August 21, 2019
• Primary Completion: April 15, 2022
• Study Completion: May 23, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)