Vestibular SchwannomaNCT04594057
Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy
A study testing Gaze and Postural Retraining Exercise in people with Vestibular Schwannoma and Vestibular Disorder, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Schwannoma, Vestibular Disorder
- What is being tested?
- Gaze and Postural Retraining Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of cardiovascular, orthopedic, or other neurologic diagnosis that limits ability to complete study testing, or causes other forms of dizziness.
- Blindness
- Peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Vestibular Schwannoma, Vestibular Disorder
- Being tested
- Gaze and Postural Retraining Exercise
- Medical subject headings
- Neuroma, Acoustic, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze and Postural Retraining ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Start | Active comparator | Begin 6 weeks of gaze and postural stability training 10-14 days following surgery. Receives: Behavioral: Gaze and Postural Retraining Exercise |
| Delayed Start | Experimental | Begin 6 weeks of gaze and postural stability training 6 weeks following surgery. Receives: Behavioral: Gaze and Postural Retraining Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change baseline to 6 weeks
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.
Measured: Change from baseline to 6 weeks
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.
Measured: Change from Baseline to 6 weeks
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.
Measured: Change from Baseline to 6 weeks
Secondary outcomes (9)
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.
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
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.
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
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.
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
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).
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Daily Step Activity
Step activity monitors will be used to quantify daily step activity during over a 4 day window.
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
Postural Sway
The amount of postural sway during quiet stance on firm, foam, and incline surfaces will be assessed using 3D accelerometers.
Measured: Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.
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.
Measured: 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
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.
Measured: Baseline, 10 days post surgery, and 12 weeks post surgery.
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.
Measured: Baseline, 10 days post surgery, and 12 weeks post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start10 Dec 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Difficulty with enrollment secondary to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594057
- Sponsor's protocol ID
- IRB_00125069
- Other IDs
- NIFTI
- Status last verified
- Oct 2020
- First submitted
- 11 Sep 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weston AR, Dibble LE, Fino P, Lisonbee R, Hoppes C, Loyd BJ. Recovery of turning speed in patients after vestibular schwannoma resection. J Vestib Res. 2024;34(2-3):145-157. doi: 10.3233/VES-230097.
PubMed 38669501
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04594057
- Acronym / sponsor ID
- IRB_00125069
- Conditions
- Vestibular Schwannoma, Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with enrollment secondary to COVID
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Start | Active comparator | Behavioral: Gaze and Postural Retraining ExerciseBegin 6 weeks of gaze and postural stability training 10-14 days following surgery. |
| Delayed Start | Experimental | Behavioral: Gaze and Postural Retraining ExerciseBegin 6 weeks of gaze and postural stability training 6 weeks following surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of cardiovascular, orthopedic, or other neurologic diagnosis that limits ability to complete study testing, or causes other forms of dizziness.
- Blindness
- Peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaze and Postural Retraining ExerciseGaze 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. | Behavioural | Delayed Start, Early Start |
Primary outcome
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.
9 secondary outcomes
Activities Balance Confidence Scale (ABC)
Time frame: 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.
Dynamic Visual Acuity
Time frame: 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.
Daily Step Activity
Time frame: 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.
Modified Physical Performance Test (mPPT)
Time frame: 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.
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.
Results and safety
The study was stopped early (reason given: Difficulty with enrollment secondary to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 38669501Weston AR, Dibble LE, Fino P, Lisonbee R, Hoppes C, Loyd BJ. Recovery of turning speed in patients after vestibular schwannoma resection. J Vestib Res. 2024;34(2-3):145-157. doi: 10.3233/VES-230097.
- Individual participant dataSharing planned: No
Related trials for Vestibular Schwannoma
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
RecruitingPhase 2
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Neurofibromatosis Type 2, Vestibular Schwannoma
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze and Postural Retraining Exercise in people with Vestibular Schwannoma and Vestibular Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty with enrollment secondary to COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dizziness Handicap Inventory (DHI) (time frame: Change baseline to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.