Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy

Vestibular Disorder Clinical Trial

Official title:

The Impact of Vestibular Rehabilitation on the Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594057
• Other study ID #: IRB_00125069
• Secondary ID: NIFTI
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: University of Utah
• Contact: Brian Loyd, PhD
• Phone: 801-587-3181
• Email: brian.loyd[@]health.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Reports of dizziness as indicated by Dizziness handicap inventory score >0
• Undergoing a vestibular schwannoma resection surgery and/or vestibular hypofunction diagnosed using bedside examination
• Able to perform community ambulation

Exclusion Criteria:

• Presence of cardiovascular, orthopedic, or other neurologic diagnosis that limits ability to complete study testing, or causes other forms of dizziness.
• Blindness
• Peripheral neuropathy

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Diseases
• Vestibular Disorder
• Vestibular Schwannoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Other	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".	Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
Other	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".	Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
Primary	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.	Change baseline to 6 weeks
Primary	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.	Change from baseline to 6 weeks
Primary	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.	Change from Baseline to 6 weeks
Primary	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.	Change from Baseline to 6 weeks
Secondary	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.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	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.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	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.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	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).	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	Daily Step Activity	Step activity monitors will be used to quantify daily step activity during over a 4 day window.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	Postural Sway	The amount of postural sway during quiet stance on firm, foam, and incline surfaces will be assessed using 3D accelerometers.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	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.	Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Secondary	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.	Baseline, 10 days post surgery, and 12 weeks post surgery.
Secondary	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.	Baseline, 10 days post surgery, and 12 weeks post surgery.