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

October 14, 2020 updated by: Brian Loyd, University of Utah

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Start
Begin 6 weeks of gaze and postural stability training 10-14 days 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.
Experimental: Delayed Start
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 baseline to 6 weeks
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 from baseline to 6 weeks
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 from Baseline to 6 weeks
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.
Change from Baseline to 6 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two-Minute Walk (2MWT)
Time Frame: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
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.
Visual Analog Scale of Dizziness
Time Frame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
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.
Visual Analog Scale of Unsteadiness
Time Frame: Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00125069
  • NIFTI (Other Grant/Funding Number: Foundation for Physical Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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