Clinical trial NCT04594057: Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vestibular Schwannoma
Vestibular Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Dizziness Handicap Inventory (DHI)
timeFrame: Change baseline to 6 weeks
measure: Change in miniBEST test
timeFrame: Change from baseline to 6 weeks
measure: Change in Community-simulated Ambulatory Task (CAT)
timeFrame: Change from Baseline to 6 weeks
measure: Change in Passive Angular Vestibular Reflex Testing
timeFrame: Change from Baseline to 6 weeks
Secondary outcomes:
measure: Activities Balance Confidence Scale (ABC)
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Life Space Assessment
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Dynamic Visual Acuity
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Compensatory Saccade Frequency
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Daily Step Activity
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Postural Sway
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Modified Physical Performance Test (mPPT)
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Line Orientation Sub-Test
timeFrame: Baseline, 10 days post surgery, and 12 weeks post surgery.
measure: Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Figure Copy Sub-Test
timeFrame: Baseline, 10 days post surgery, and 12 weeks post surgery.
Other outcomes:
measure: Two-Minute Walk (2MWT)
timeFrame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
measure: Visual Analog Scale of Dizziness
timeFrame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
measure: Visual Analog Scale of Unsteadiness
timeFrame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: