Multiple SclerosisGPSNCT03521557
Gaze and Postural Stability in Multiple Sclerosis
A study testing Gaze and Postural Stability in people with Multiple Sclerosis and Vertigo, run by University of Utah at 1 site in United States.
Trial summary
In order to provide information that will improve therapy, the goals of this project are to determine if persons with MS with complaints of dizziness and at risk for falls can improve their balance and vision stability as a result of a bout of specific treatment. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Vertigo, Dizziness
- What is being tested?
- Gaze and Postural Stability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 30 Sep 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurologist-diagnosed, clinically definite MS
- Expanded Disability Severity Scale (EDSS) score of less than 6.0
- Current complaints of dizziness (DHI > 0)
- At risk of falls (determined by > 2 falls in past year or Dynamic Gait Index <19 or Activity Specific Balance Confidence Scale <80
- Ability to tolerate repetitive 5 min bouts of angular head motions.
Who cannot join
- Central or Peripheral Nervous System disorders (other than MS)
- Otologic, Cervical spine, or lower extremity injury in last 12 months
- Exercise or alcohol use in last 48 hours
- Currently taking vestibular suppressant medications
- Peripheral Vestibular Pathology (BPPV, hypofunction, Meniere's disease
- Internuclear Opthalmoplegia
- MS exacerbation within last 8 weeks
- Orthopedic, neurologic, or cognitive comorbidities that would limit participation in the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaze and Postural Stability in People With MS: Characterizing Deficits and Response to Treatment
In order to provide information that will improve therapy, the goals of this project are to determine if persons with MS with complaints of dizziness and at risk for falls can improve their balance and vision stability as a result of a bout of specific treatment. This project seeks to do this by conducting an experiment where people with MS are randomly assigned to a group that practices activities known to help improve inner ear function or a group that practices activities known to improve endurance and strength but that should not change inner ear function. Such a comparison will allow us to gain understanding of how the inner ear system is affected in MS and how it responds to treatment.
Read the detailed description
A variety of sources of evidence suggest altered vestibular function in people diagnosed with MS (PwMS). These sources of evidence include [a] subjective complaints of dizziness / vertigo, [b] altered subjective visual vertical, [c] altered vestibular evoked myogenic potentials, [d] altered performance on the vestibular dominant components of the sensory organization test, and [e] pilot reports of gaze stabilization deficits during vestibular ocular reflex (VOR) testing from the investigator's research group. These findings suggest vestibular deficits are present in PwMS. Epidemiological studies document cerebellar and brainstem involvement in 23% of PwMS at disease onset, increasing to 82% after longstanding illness. These vestibular deficits contribute to motion sensitivity, dizziness, imbalance, and falls. Regardless, dizziness and falls have a significant negative impact on quality of life. Multiple studies show that falls are a major disabling symptom in MS affecting approximately 75% of PwMS. The high incidence of falls in MS, is an important health concern due to its associations with injury-related morbidities, mortality and financial costs.
The vestibular pathways responsible for gaze and postural stability, as well as sensory integration reside in the brainstem, cerebellum and spinal cord. Demyelination of the pathways involving the vestibular nuclei complex within the brainstem and cerebellum adversely affect angular vestibulo-ocular reflex,vestibulo-spinal reflex function and sensory integration in PwMS. While evidence reports impairments in posturography and otolith mediated responses (vestibular evoked myogenic potentials), the responses mediated by the semicircular canal end organs and vestibular pathways have not been examined. Specifically, the learning and retention of gaze and postural stability as a result of task specific training program has not been studied in a well controlled clinical trial.
This proposal seeks to examine gaze and postural stability outcomes utilizing outcome measures that span the World Health Organization's International Classification of Function, Disability, and Health. Following completion of the baseline examination, PwMS will be randomized to one of two interventions: An Experimental Gaze and Postural Stability Training Group (GPS) or a Standard Care Aerobic Exercise Control Group (SCA). The two groups differ only by the presence of the GPS program in the experimental group. Both groups will participate in supervised exercise 3 times per week for 6 weeks followed by a post intervention testing period . After one month of no training, both groups will be brought back for a final follow-up examination to determine the retention of any training induced changes.
- Conditions
- Multiple Sclerosis, Vertigo, Dizziness, Falls Injury
- Being tested
- Gaze and Postural Stability, Standard Care Control
- Medical subject headings
- Multiple Sclerosis, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze and Postural StabilityBehavioural
Also called GPS
The duration and content of the GPS intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises.
Standard Care ControlBehavioural
Also called Standard Care Control (SCC)
The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength.
| Study group | Role | What they receive |
|---|---|---|
| Gaze and Postural Stability | Experimental | 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. Receives: Behavioral: Gaze and Postural Stability; Behavioral: Standard Care Control |
| Standard Care Control | Active comparator | The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength. The target duration of each in clinic visit will be 90 min (30 min of aerobic exercise, 30 min of lower extremity resistance exercises, and 30 min of rest interspersed throughout the exercise session. Receives: Behavioral: Standard Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
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.[72-76]. 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. Collected at intervention completion, adjusting for baseline (DHI values collected at baseline assessment, prior to intervention).
Measured: At intervention completion (6 weeks)
Secondary outcomes (12)
Dizziness Handicap Inventory Follow-up
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.[72-76]. 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. Collected at 1-month follow-up, adjusting for baseline (DHI values collected at baseline assessment, prior to intervention).
Measured: 1-month follow-up post intervention (10 weeks)
Activity Specific Balance Confidence Scale
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. Collected at intervention completion and 1 month follow-up adjusted for baseline (values collected prior to intervention).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Functional Gait Assessment
The Functional Gait Assessment (FGA) is a 10-item measure that examines dynamic stability during various walking tasks on a marked 6-m (20-ft) length and 12-inch wide walkway. Each item is rated from 0-3 with higher scores indicating better dynamic stability. Tasks within the FGA require head and / or body motion during walking activities which will be assessed using body-worn 3D accelerometers. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Mini-BEST 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.[37] 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. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
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. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Passive Angular Vestibulo-ocular Reflex Gain
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. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
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: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Compensatory Saccade Latency
The Compensatory Saccade (CS) latency is the duration of time between the onset of head acceleration to onset of first identifiable CS. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Gaze Position Error
Gaze position error is calculated as the visual target position minus the eye position at the end of the head impulse. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Margin of stability
the margin of dynamic stability. Margin of dynamic stability characterizes the distance between the base of support and the extrapolated center of mass (a measure which incorporates the position and velocity of the center of mass. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Step Latency
The step latency will be calculated as the time period between tether release and foot off of the stepping limb. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Postural Sway
The amount of postural sway during quiet stance on firm, foam, and incline surfaces will be assessed using 3D accelerometers. Collected at intervention completion and 1-month follow-up adjusting for baseline (values collected at baseline assessment).
Measured: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start29 May 2018
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- 2 group x 3 time interval
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Arizona State University, Johns Hopkins University
- Responsible party
- Principal investigator, Lee Dibble, University of Utah
- Investigators
- Lee Dibble, PhD, PT, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521557
- Sponsor's protocol ID
- IRB_00104298
- Acronym
- GPS
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2017
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loyd BJ, Saviers-Steiger J, Fangman A, Ballard P, Taylor C, Schubert M, Dibble L. Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors. J Neurol Phys Ther. 2020 Oct;44(4):261-267. doi: 10.1097/NPT.0000000000000329.
PubMed 32815892Loyd BJ, Fangman A, Peterson DS, Gappmaier E, Schubert MC, Thackery A, Dibble L. Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: study protocol for a prospective randomized clinical trial. BMC Neurol. 2019 Jun 10;19(1):119. doi: 10.1186/s12883-019-1353-z.
PubMed 31179920
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze and Postural Stability in People With MS: Characterizing Deficits and Response to Treatment
- ClinicalTrials.gov ID
- NCT03521557
- Acronym / sponsor ID
- GPS / IRB_00104298
- Conditions
- Multiple Sclerosis, Vertigo, Dizziness, Falls Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Arizona State University, Johns Hopkins University
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 May 2018 (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.
In order to provide information that will improve therapy, the goals of this project are to determine if persons with MS with complaints of dizziness and at risk for falls can improve their balance and vision stability as a result of a bout of specific treatment. This project seeks to do this by conducting an experiment where people with MS are randomly assigned to a group that practices activities known to help improve inner ear function or a group that practices activities known to improve endurance and strength but that should not change inner ear function. Such a comparison will allow us to gain understanding of how the inner ear system is affected in MS and how it responds to treatment.
Detailed description
A variety of sources of evidence suggest altered vestibular function in people diagnosed with MS (PwMS). These sources of evidence include [a] subjective complaints of dizziness / vertigo, [b] altered subjective visual vertical, [c] altered vestibular evoked myogenic potentials, [d] altered performance on the vestibular dominant components of the sensory organization test, and [e] pilot reports of gaze stabilization deficits during vestibular ocular reflex (VOR) testing from the investigator's research group. These findings suggest vestibular deficits are present in PwMS. Epidemiological studies document cerebellar and brainstem involvement in 23% of PwMS at disease onset, increasing to 82% after longstanding illness. These vestibular deficits contribute to motion sensitivity, dizziness, imbalance, and falls. Regardless, dizziness and falls have a significant negative impact on quality of life. Multiple studies show that falls are a major disabling symptom in MS affecting approximately 75% of PwMS. The high incidence of falls in MS, is an important health concern due to its associations with injury-related morbidities, mortality and financial costs.
The vestibular pathways responsible for gaze and postural stability, as well as sensory integration reside in the brainstem, cerebellum and spinal cord. Demyelination of the pathways involving the vestibular nuclei complex within the brainstem and cerebellum adversely affect angular vestibulo-ocular reflex,vestibulo-spinal reflex function and sensory integration in PwMS. While evidence reports impairments in posturography and otolith mediated responses (vestibular evoked myogenic potentials), the responses mediated by the semicircular canal end organs and vestibular pathways have not been examined. Specifically, the learning and retention of gaze and postural stability as a result of task specific training program has not been studied in a well controlled clinical trial.
This proposal seeks to examine gaze and postural stability outcomes utilizing outcome measures that span the World Health Organization's International Classification of Function, Disability, and Health. Following completion of the baseline examination, PwMS will be randomized to one of two interventions: An Experimental Gaze and Postural Stability Training Group (GPS) or a Standard Care Aerobic Exercise Control Group (SCA). The two groups differ only by the presence of the GPS program in the experimental group. Both groups will participate in supervised exercise 3 times per week for 6 weeks followed by a post intervention testing period . After one month of no training, both groups will be brought back for a final follow-up examination to determine the retention of any training induced changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 group x 3 time interval
| Arm | Type | Receives |
|---|---|---|
| Gaze and Postural Stability | Experimental | Behavioral: Gaze and Postural Stability, Behavioral: Standard Care ControlThe 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. |
| Standard Care Control | Active comparator | Behavioral: Standard Care ControlThe Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength. The target duration of each in clinic visit will be 90 min (30 min of aerobic exercise, 30 min of lower extremity resistance exercises, and 30 min of rest interspersed throughout the exercise session. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neurologist-diagnosed, clinically definite MS
- Expanded Disability Severity Scale (EDSS) score of less than 6.0
- Current complaints of dizziness (DHI > 0)
- At risk of falls (determined by > 2 falls in past year or Dynamic Gait Index <19 or Activity Specific Balance Confidence Scale <80
- Ability to tolerate repetitive 5 min bouts of angular head motions.
Key exclusion criteria (8 listed)
- Central or Peripheral Nervous System disorders (other than MS)
- Otologic, Cervical spine, or lower extremity injury in last 12 months
- Exercise or alcohol use in last 48 hours
- Currently taking vestibular suppressant medications
- Peripheral Vestibular Pathology (BPPV, hypofunction, Meniere's disease
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 StabilityAlso: GPSThe duration and content of the GPS intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises. | Behavioural | Gaze and Postural Stability |
| Standard Care ControlAlso: Standard Care Control (SCC)The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength. | Behavioural | Gaze and Postural Stability, Standard Care Control |
Primary outcome
Dizziness Handicap Inventory
Time frame: At intervention completion (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.[72-76]. 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. Collected at intervention completion, adjusting for baseline (DHI values collected at baseline assessment, prior to intervention).
12 secondary outcomes
Dizziness Handicap Inventory Follow-up
Time frame: 1-month follow-up post intervention (10 weeks)
Activity Specific Balance Confidence Scale
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Functional Gait Assessment
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Mini-BEST test
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Dynamic Visual Acuity
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Passive Angular Vestibulo-ocular Reflex Gain
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Compensatory Saccade Frequency
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Compensatory Saccade Latency
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Gaze Position Error
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Margin of stability
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Step Latency
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Postural Sway
Time frame: At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 32815892Loyd BJ, Saviers-Steiger J, Fangman A, Ballard P, Taylor C, Schubert M, Dibble L. Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors. J Neurol Phys Ther. 2020 Oct;44(4):261-267. doi: 10.1097/NPT.0000000000000329.
- Derived from this study: PubMed 31179920Loyd BJ, Fangman A, Peterson DS, Gappmaier E, Schubert MC, Thackery A, Dibble L. Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: study protocol for a prospective randomized clinical trial. BMC Neurol. 2019 Jun 10;19(1):119. doi: 10.1186/s12883-019-1353-z.
- Individual participant dataSharing planned: No
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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.
Lee Dibble, PhD, PT principal investigator
University of Utah
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 Stability in people with Multiple Sclerosis and Vertigo, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dizziness Handicap Inventory (time frame: At intervention completion (6 weeks)). 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 NCT03521557, which also lists 2 linked publications.
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 6 Oct 2021.