Vestibular DiseasesNCT03553264
Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
A study testing Virtual Reality Rehabilitation and Vestibular Rehabilitation in people with Vestibular Diseases and Virtual Rehabilitation, run by Uniter Onlus at 1 site in Italy.
Trial summary
The aim of the present study will be to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vestibular Diseases, Virtual Rehabilitation
- What is being tested?
- Virtual Reality Rehabilitation and Vestibular Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2016to Dec 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- right-handed patients affected by right chronic Unilateral Vestibular Hypofunction, the diagnosis of which will be achieved with at least 25% reduced vestibular response at bithermal water caloric irrigations on one side when calculated by means of Jongkees' formula after at least 3 months from the onset of symptoms.
Who cannot join
- negative anamnesis for malignancy,
- negative anamnesis for head trauma,
- negative anamnesis for neuropsychiatric disorders
- negative anamnesis for metabolic diseases
- negative anamnesis for cardiovascular diseases
- negative anamnesis for endocrine diseases
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- treatment with drugs possibly impacting on auditory and visuo-vestibular functions
- negative anamnesis for infectious diseases
- negative anamnesis for otoneurological diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UNITER ONLUS for balance and rehabilitation research
Guidonia, Rome, 00012
Alessandro Micarelli, M.D.,Ph.D., 0039-3356222157, alessandromicarelli@yahoo.it
Andrea Viziano, M.D., 0039-3485830254, andrea.viziano@gmail.com
About this study
Official title: Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial
The aim of the present study will be to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Main outcomes will be: otoneurological testing (vestibulo-ocular reflex gain study by means of vHIT and posturography measures with particular attention on power spectra) and self-report and performance measures (DHI, DGI and ABC). Side effects of HMD implementation will be studied by means of Simulator Sickness Questionnaires.
Moreover, second part of the study would collect patients' data one year after the end of the vestibular rehabilitation or its implementation with HMD.
Read the detailed description
Due to the recent outbreak of virtual reality in the field of rehabilitation, the use of head-mounted devices has been proposed in addition to conventional vestibular rehabilitation therapy in unilateral vestibular hypofunction patients. This approach has been proved to be useful in maximizing vestibular rehabilitation outcomes, with minimum simulator-related side effects. Virtual reality-based devices have been tested in vestibular rehabilitation by many clinicians, due to the possibility of achieving habituation, substitution and adaptation, the effectiveness in people presenting visual vertigo, and the positive effects on anxiety.
Thus, due to the undeniable relevance of testing outcomes of vestibular rehabilitation, and the promising results of head-mounted device-based home exercises in ameliorating its effects, the aim of this study will be to compare - in terms of short- (one week) and long-term (one year) effects - the subjective and objective indicators of vestibular function in a population of patients with unilateral vestibular hypofunction after completing conventional vestibular rehabilitation therapy with a randomized group who underwent a mixed-methods protocol including vestibular rehabilitation and head-mounted device treatment over the same period of time.
- Conditions
- Vestibular Diseases, Virtual Rehabilitation
- Being tested
- Virtual Reality Rehabilitation, Vestibular Rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality RehabilitationDevice
Track Speed Racing 3D game will run with HMD 'Revelation' 3D VR Headset and each HMD group patient will be instructed to perform the game protocol uninterruptedly for 20min/day, while sitting on a chair or sofa.
Vestibular RehabilitationOther
The home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Head Mounted Device | Experimental | In addition to the Vestibular Rehabilitation protocol, each HMD group patient will perform Virtual Reality Rehabilitation by means of the game protocol "Track Speed Racing 3D" uninterruptedly for 20min/day, while sitting on a chair or sofa, after the smartphone accommodation into the HMD 'Revelation' 3D VR Headset. The game consists of a point-of-view race in which the car is steered from the cockpit by tilting the head to the left and to the right to avoid swerving off the road and to achieve all the goals before finishing the lap. During this real car experience, the visual background and the scenario change perspective according to the patients' left or right tilted head movements, possibly emulating eye-head exercises that induce visual-vestibular conflicts. Receives: Device: Virtual Reality Rehabilitation; Other: Vestibular Rehabilitation |
| Vestibular Rehabilitation | Active comparator | Patients will be actively involved in adapting the exercise program to suit their symptoms, capabilities, and lifestyle. Following previous protocols, the home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises, and all chronic unilateral vestibular hypofunction patients will be seen twice a week for 4 weeks for 30-45 min and monitored for adherence. Between supervised sessions, patients will perform a twice-daily home exercise program for a total of 30-40min/day. Receives: Other: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otoneurological Test
Study of vestibulo-ocular reflex VOR) by means of vHIT measuring its gain as the ratio between head and eye velocity. Low VOR gain values (range: 0.8-1) indicate low levels of activity of the semicircular canal.
Measured: one month
Secondary outcomes (4)
Balance Test
Study of the surface of the ellipse of confidence (mm) by means of static posturography platform will be used to assess the sway of the posture. Low levels of outcomes indicate better performances. No specific reference ranges are given in literature.
Measured: one month
Self-report dizziness handicap
The Italian Dizziness Handicap Inventory (DHI) wil be used to assess the self-report dizziness handicap. It consists of 25 questions designed to assess a patient's functional (nine questions), emotional (nine questions), and physical (seven questions) limitations; scores range from 0 to 100, with moderate and severe disability usually associated with scores above 30 and 60, respectively
Measured: one month
Balance Confidence
The Activities-specific Balance Confidence scale will be used to record the patient's perceived level of balance confidence during 16 everyday activities ranging from 0 to 100%. Higher values are referred to better balance confidence. No cut-off are given in literature.
Measured: one month
Gait
The Dynamic Gait Index will examin the patient's ability to perform various gait activities on an eight-item scale; range is from 0 to 24, with scores less than 19 indicating increased risk of falls.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startAug 2016
- Primary completionMay 2018
- Study completionDec 2018 (estimated)
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 Vestibular DiseasesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniter Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Sponsor
- Investigators
- Alessandro Micarelli, M.D.,Ph.D., Principal investigator, Uniter Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553264
- Sponsor's protocol ID
- UniterHMD
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. Epub 2015 Apr 30.
PubMed 26556560Alahmari KA, Sparto PJ, Marchetti GF, Redfern MS, Furman JM, Whitney SL. Comparison of virtual reality based therapy with customized vestibular physical therapy for the treatment of vestibular disorders. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):389-99. doi: 10.1109/TNSRE.2013.2294904.
PubMed 24608691
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial
- ClinicalTrials.gov ID
- NCT03553264
- Acronym / sponsor ID
- UniterHMD
- Conditions
- Vestibular Diseases, Virtual Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uniter OnlusUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jun 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.
The aim of the present study will be to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Main outcomes will be: otoneurological testing (vestibulo-ocular reflex gain study by means of vHIT and posturography measures with particular attention on power spectra) and self-report and performance measures (DHI, DGI and ABC). Side effects of HMD implementation will be studied by means of Simulator Sickness Questionnaires.
Moreover, second part of the study would collect patients' data one year after the end of the vestibular rehabilitation or its implementation with HMD.
Detailed description
Due to the recent outbreak of virtual reality in the field of rehabilitation, the use of head-mounted devices has been proposed in addition to conventional vestibular rehabilitation therapy in unilateral vestibular hypofunction patients. This approach has been proved to be useful in maximizing vestibular rehabilitation outcomes, with minimum simulator-related side effects. Virtual reality-based devices have been tested in vestibular rehabilitation by many clinicians, due to the possibility of achieving habituation, substitution and adaptation, the effectiveness in people presenting visual vertigo, and the positive effects on anxiety.
Thus, due to the undeniable relevance of testing outcomes of vestibular rehabilitation, and the promising results of head-mounted device-based home exercises in ameliorating its effects, the aim of this study will be to compare - in terms of short- (one week) and long-term (one year) effects - the subjective and objective indicators of vestibular function in a population of patients with unilateral vestibular hypofunction after completing conventional vestibular rehabilitation therapy with a randomized group who underwent a mixed-methods protocol including vestibular rehabilitation and head-mounted device treatment over the same period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Mounted Device | Experimental | Device: Virtual Reality Rehabilitation, Other: Vestibular RehabilitationIn addition to the Vestibular Rehabilitation protocol, each HMD group patient will perform Virtual Reality Rehabilitation by means of the game protocol "Track Speed Racing 3D" uninterruptedly for 20min/day, while sitting on a chair or sofa, after the smartphone accommodation into the HMD 'Revelation' 3D VR Headset. The game consists of a point-of-view race in which the car is steered from the cockpit by tilting the head to the left and to the right to avoid swerving off the road and to achieve all the goals before finishing the lap. During this real car experience, the visual background and the scenario change perspective according to the patients' left or right tilted head movements, possibly emulating eye-head exercises that induce visual-vestibular conflicts. |
| Vestibular Rehabilitation | Active comparator | Other: Vestibular RehabilitationPatients will be actively involved in adapting the exercise program to suit their symptoms, capabilities, and lifestyle. Following previous protocols, the home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises, and all chronic unilateral vestibular hypofunction patients will be seen twice a week for 4 weeks for 30-45 min and monitored for adherence. Between supervised sessions, patients will perform a twice-daily home exercise program for a total of 30-40min/day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- right-handed patients affected by right chronic Unilateral Vestibular Hypofunction, the diagnosis of which will be achieved with at least 25% reduced vestibular response at bithermal water caloric irrigations on one side when calculated by means of Jongkees' formula after at least 3 months from the onset of symptoms.
Key exclusion criteria (9 listed)
- negative anamnesis for malignancy,
- negative anamnesis for head trauma,
- negative anamnesis for neuropsychiatric disorders
- negative anamnesis for metabolic diseases
- negative anamnesis for cardiovascular diseases
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 |
|---|---|---|
| Virtual Reality RehabilitationTrack Speed Racing 3D game will run with HMD 'Revelation' 3D VR Headset and each HMD group patient will be instructed to perform the game protocol uninterruptedly for 20min/day, while sitting on a chair or sofa. | Device | Head Mounted Device |
| Vestibular RehabilitationThe home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises | Other | Head Mounted Device, Vestibular Rehabilitation |
Primary outcome
Otoneurological Test
Time frame: one month
Study of vestibulo-ocular reflex VOR) by means of vHIT measuring its gain as the ratio between head and eye velocity. Low VOR gain values (range: 0.8-1) indicate low levels of activity of the semicircular canal.
4 secondary outcomes
Balance Test
Time frame: one month
Self-report dizziness handicap
Time frame: one month
Balance Confidence
Time frame: one month
Gait
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Background: PubMed 26556560Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. Epub 2015 Apr 30.
- Results publication: PubMed 24608691Alahmari KA, Sparto PJ, Marchetti GF, Redfern MS, Furman JM, Whitney SL. Comparison of virtual reality based therapy with customized vestibular physical therapy for the treatment of vestibular disorders. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):389-99. doi: 10.1109/TNSRE.2013.2294904.
- 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.
Alessandro Micarelli, M.D.,Ph.D. principal investigator
Uniter Onlus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Rehabilitation and Vestibular Rehabilitation in people with Vestibular Diseases and Virtual Rehabilitation, run by Uniter Onlus at 1 site in Italy.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Jun 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Micarelli, M.D.,Ph.D. (0039-3356222157, alessandromicarelli@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Otoneurological Test (time frame: one month). 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 NCT03553264, 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 12 Jun 2018.