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Clinical Trials/NCT04594057
NCT04594057
Terminated
N/A

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

University of Utah1 site in 1 country10 target enrollmentDecember 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vestibular Schwannoma
Sponsor
University of Utah
Enrollment
10
Locations
1
Primary Endpoint
Change in Dizziness Handicap Inventory (DHI)
Status
Terminated
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 10, 2019
End Date
December 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Dizziness Handicap Inventory (DHI)

Time Frame: Change baseline to 6 weeks

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 in miniBEST test

Time Frame: Change from baseline to 6 weeks

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 in Community-simulated Ambulatory Task (CAT)

Time Frame: Change from Baseline to 6 weeks

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 in Passive Angular Vestibular Reflex Testing

Time Frame: Change from Baseline to 6 weeks

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.

Secondary Outcomes

  • Activities Balance Confidence Scale (ABC)(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Life Space Assessment(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Dynamic Visual Acuity(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Compensatory Saccade Frequency(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Daily Step Activity(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Postural Sway(Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.)
  • Modified Physical Performance Test (mPPT)(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(Baseline, 10 days post surgery, and 12 weeks post surgery.)
  • Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Figure Copy Sub-Test(Baseline, 10 days post surgery, and 12 weeks post surgery.)

Study Sites (1)

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