An interventional study of Gaze and Postural Retraining Exercise in Vestibular Schwannoma and Vestibular Disorder, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
This study is designed to examine the true impact inner-ear dysfunction has on patient head movement kinematics, activity levels, and participation, and (2) to explore the efficacy of rehabilitation on laboratory, clinical, and community-based outcomes in people following surgical removal of a schwannoma from the inner-ear nerve.
In this project we will focus on characterizing deficits in community-based performance (i.e., head and trunk control during simulated community activities, short term community mobility, and patient reported participation) and relating these deficits to laboratory (i.e., video head impulse testing and corrective postural responses) and clinical (i.e., MiniBEST and dynamic visual acuity, and visual spatial cognition) measures of gaze and postural stability in individuals with varied forms of vestibulopathy (unilateral vestibular neuritis, bilateral vestibular loss, migraine related vestibulopathy, concussion, BPPV, Multiple Sclerosis). Additionally, we will examine the longitudinal change of laboratory, and community-based measures of gaze and postural in two cohorts of people with a specific form of unilateral vestibular loss (Vestibular Schwannoma resection); one group of these individuals will receive 6 weeks of vestibular rehabilitation during the acute onset of symptoms and the other one will begin intervention 6 weeks post onset. This portion of the proposed project will test my global hypothesis that changes in community-based performance of head and trunk control impair recovery following the onset of VH.
Aim 1: In individuals with vestibulopathy, characterize and compare laboratory and clinical measures of body structure, function, and performance to community-based, activity levels, performance, and patient reported participation. Hypothesis 1: The severity of laboratory and clinically measured gaze and postural stability function deficits will not strongly correlate with head and trunk control during community-based performance or patient reported participation. Hypothesis 2: The nature and severity of laboratory and clinically measured gaze and postural stability function deficits will differ between varied diagnostic groups.
Aim 2: In individuals with unilateral vestibular hypofunction following unilateral vestibular schwannoma resection, examine the longitudinal trajectories of laboratory and clinical measures of body structure, function and performance, and community-based performance, activity levels, and patient reported participation during periods of spontaneous and rehabilitation driven recovery. Hypothesis: Recovery of laboratory and clinical measures will follow different trajectories than measures of community-based performance and patient reported participation during both periods of spontaneous and rehabilitation driven recovery.
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Exclusion Criteria:
Begin 6 weeks of gaze and postural stability training 10-14 days following surgery.
Behavioral: Gaze and Postural Retraining Exercise
Begin 6 weeks of gaze and postural stability training 6 weeks following surgery.
Behavioral: Gaze and Postural Retraining Exercise
Gaze and Postural Stability The duration and content of the Gaze and Postural Stability (GPS) intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises. The target duration of each in clinic visit will be 90 min (15 min of gaze stability exercises, 15 min of postural stability exercises and approximately 60 min for the standard care control intervention with rest interspersed throughout the exercise session. Gaze stability exercise will consist of progressive Vestibular-occular training. Postural stability exercises will consist of progressive static and dynamic postural training.
Change in Dizziness Handicap Inventory (DHI)
Dizziness Handicap Inventory (DHI): The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability in PwMS. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap. Change from baseline to 6 weeks post surgery.
Time frame: Change baseline to 6 weeks
Change in miniBEST test
the 14-item Mini-BESTest which includes four sections (anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait) relevant to postural control and stability in MS. The maximum possible score is 28 with higher scores indicating better balance. Tasks within the Mini-BEST test require head and/ or body motion, which will be assessed using body-worn 3D accelerometers. The Change from the baseline score to the 6 weeks post surgery score.
Time frame: Change from baseline to 6 weeks
Change in Community-simulated Ambulatory Task (CAT)
Community-simulated walking task consisting of turns, stairs, and inside/outside ambulation requiring specific use of head and trunk turns. Change from baseline to 6 weeks post surgery.
Time frame: Change from Baseline to 6 weeks
Change in Passive Angular Vestibular Reflex Testing
The angular vestibular ocular reflex (aVOR) gain will be calculated as the ratio of the de-saccaded eye velocity Area Under the Curve (AUC) over the head velocity AUC between the onset of the head impulse to the moment when head velocity returns to zero. Change from baseline to 6 weeks post surgery in aVOR gain.
Time frame: Change from Baseline to 6 weeks
Activities Balance Confidence Scale (ABC)
The Activity Specific Balance Confidence Scale (ABC) is a 16-item self-reported measure of balance confidence in performing various activities of daily living. Each question requires an individual to grade his or her self on a scale of 0 to 100 percent for their level of confidence and higher scores indicate greater balance confidence in performing these activities.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Life Space Assessment
The Life Space Assessment is self-report questionnaire that captures the amount of time which a person interacts with differing levels of their environment.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Dynamic Visual Acuity
The Dynamic Visual Acuity (DVA) test is a valid and reliable functional measure of gaze stability that utilizes head rotations representing natural head velocities during daily activities. The variable logMAR is the standard measurement for DVA and is equal to log10x, where x is the minimum angle resolved, in arcmin, with 1 arcmin equal to 1/60°). The better one's visual acuity, the lower one's logMAR score.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Compensatory Saccade Frequency
The number of Compensatory Saccades (CS) per Head Rotation (CS/HR) will be manually counted per head rotation. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Daily Step Activity
Step activity monitors will be used to quantify daily step activity during over a 4 day window.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Postural Sway
The amount of postural sway during quiet stance on firm, foam, and incline surfaces will be assessed using 3D accelerometers.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Modified Physical Performance Test (mPPT)
The mPPT assess basic and complex activities of daily living including rising from a chair, picking an object up from the floor, donning and doffing a jacket, placing an item on a shelf, a 50 foot walk, 360 degree turns, and ascending an descending stairs.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Line Orientation Sub-Test
A test of visual spatial cognition that requires the participant to try and correctly identify the orientation of two lines presented to them with 12 other line options. Scores range from 0-20 based on correctness of line orientation on 10 different trials.
Time frame: Baseline, 10 days post surgery, and 12 weeks post surgery.
Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Figure Copy Sub-Test
A test of visual spatial cognition that requires the participant to copy a multiple shape figure and is scored from 0-20 based on the correctness of the figure copy.
Time frame: Baseline, 10 days post surgery, and 12 weeks post surgery.
Two-Minute Walk (2MWT)
The distance walked in 2 minutes (Two-Minute Walk \[2MWT\]) is a valid and reliable measure of locomotor ability in populations with a variety of chronic diseases. Higher values reflect greater ability.
Time frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Visual Analog Scale of Dizziness
A single mark will be made along a 10 cm line indicating the amount of dizziness experienced ranging from "no dizziness" to "worst possible dizziness".
Time frame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
Visual Analog Scale of Unsteadiness
A single mark will be made along a 10 cm line indicating the amount of unsteadiness experienced ranging from "no unsteadiness" to "worst possible unsteadiness".
Time frame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
Plan to share: No
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