Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy
Primary Purpose
Vestibular Schwannoma, Vestibular Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gaze and Postural Retraining Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Schwannoma
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
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Early Start
Delayed Start
Arm Description
Begin 6 weeks of gaze and postural stability training 10-14 days following surgery.
Begin 6 weeks of gaze and postural stability training 6 weeks following surgery.
Outcomes
Primary Outcome Measures
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 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 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 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.
Secondary Outcome Measures
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.
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.
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.
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).
Daily Step Activity
Step activity monitors will be used to quantify daily step activity during over a 4 day window.
Postural Sway
The amount of postural sway during quiet stance on firm, foam, and incline surfaces will be assessed using 3D accelerometers.
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.
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.
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.
Full Information
NCT ID
NCT04594057
First Posted
September 11, 2020
Last Updated
October 14, 2020
Sponsor
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT04594057
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma, Vestibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Start
Arm Type
Active Comparator
Arm Description
Begin 6 weeks of gaze and postural stability training 10-14 days following surgery.
Arm Title
Delayed Start
Arm Type
Experimental
Arm Description
Begin 6 weeks of gaze and postural stability training 6 weeks following surgery.
Intervention Type
Behavioral
Intervention Name(s)
Gaze and Postural Retraining Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Dizziness Handicap Inventory (DHI)
Description
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
Title
Change in miniBEST test
Description
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
Title
Change in Community-simulated Ambulatory Task (CAT)
Description
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
Title
Change in Passive Angular Vestibular Reflex Testing
Description
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
Secondary Outcome Measure Information:
Title
Activities Balance Confidence Scale (ABC)
Description
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.
Title
Life Space Assessment
Description
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.
Title
Dynamic Visual Acuity
Description
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.
Title
Compensatory Saccade Frequency
Description
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.
Title
Daily Step Activity
Description
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.
Title
Postural Sway
Description
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.
Title
Modified Physical Performance Test (mPPT)
Description
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.
Title
Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Line Orientation Sub-Test
Description
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.
Title
Repeated Battery of the Assessment of Neuropsychological Status (RBANS): Figure Copy Sub-Test
Description
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.
Other Pre-specified Outcome Measures:
Title
Two-Minute Walk (2MWT)
Description
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.
Title
Visual Analog Scale of Dizziness
Description
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.
Title
Visual Analog Scale of Unsteadiness
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Loyd, PhD
Phone
801-587-3181
Email
brian.loyd@health.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Dibble, PhD
Phone
801-587-3181
Email
lee.dibble@hsc.utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Loyd, PhD
Phone
801-587-3181
Email
brian.loyd@health.utah.edu
First Name & Middle Initial & Last Name & Degree
Lee Dibble, PhD
Phone
801-587-3181
Email
lee.dibble@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy
We'll reach out to this number within 24 hrs