Postural VertigoNCT04367194
Objective Examination and Rehabilitation Treatment of Patients With BPPV
A study testing Neurorehabilitation in people with Postural Vertigo and Vertigo, Paroxysmal, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability. In the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Postural Vertigo, Vertigo, Paroxysmal, Vertigo, Positional
- What is being tested?
- Neurorehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 23 Apr 2018to 23 Jun 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For a patient with BPPV
- With a lack of coordination
- Dizziness
- Ear nose laryngeal examination
- Neurological examination
Who cannot join
- other neurological diseases
- cardiological diseases
- underwent surgery
- severe joint pain
- alcoholism
- dementia
- drug
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400
About this study
Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability.
In the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined.
After the results, the patients undergo a rehabilitation training. The workout is submaximal and high intensity that is done for 3 weeks.
Hypothesis: As a result of training, it is possible that the remaining feeling of dizziness and insecurity, impaired coordination will decrease or disappear.
- Conditions
- Postural Vertigo, Vertigo, Paroxysmal, Vertigo, Positional, Coordination Disorder, Developmental, Coordination and Balance Disturbances
- Being tested
- Neurorehabilitation
- Keywords
- vertigo, balance, instability, rehabilitation
- Medical subject headings
- Vertigo, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurorehabilitationBehavioural
Also called BPPV group
After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.
| Study group | Role | What they receive |
|---|---|---|
| BPPV intervention | Experimental | After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training. Receives: Behavioral: Neurorehabilitation |
| BPPV Epley | Experimental | Only Epley training. Receives: Behavioral: Neurorehabilitation |
| BPPV Optocinetic | Experimental | Only Optocinetic training. Receives: Behavioral: Neurorehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D-5L
Quality of life testing is taken with a test. The therapist scores the answers to the questions asked on a scale. The end result determines the quality of life.
Measured: 5 weeks
Beam Walking test
The patient walks on slats of varying width. During the examination, the therapist says the tasks (Eg: counting backwards). The study detects the determination of dynamic equilibrium.
Measured: 5 weeks
Posturography
Noninvasive intervention where static equilibrium is examined. The program determines the quality and frequency of the displacements.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start23 Apr 2018
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural VertigoStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367194
- Sponsor's protocol ID
- IKEB2019/15
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Examination and Rehabilitation Treatment of Patients With BPPV
- ClinicalTrials.gov ID
- NCT04367194
- Acronym / sponsor ID
- IKEB2019/15
- Conditions
- Postural Vertigo, Vertigo, Paroxysmal, Vertigo, Positional, Coordination Disorder, Developmental, Coordination and Balance Disturbances
- Keywords
- vertigo, balance, instability, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 29 Apr 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.
Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability.
In the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined.
After the results, the patients undergo a rehabilitation training. The workout is submaximal and high intensity that is done for 3 weeks.
Hypothesis: As a result of training, it is possible that the remaining feeling of dizziness and insecurity, impaired coordination will decrease or disappear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPPV intervention | Experimental | Behavioral: NeurorehabilitationAfter examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training. |
| BPPV Epley | Experimental | Behavioral: NeurorehabilitationOnly Epley training. |
| BPPV Optocinetic | Experimental | Behavioral: NeurorehabilitationOnly Optocinetic training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For a patient with BPPV
- With a lack of coordination
- Dizziness
- Ear nose laryngeal examination
- Neurological examination
Key exclusion criteria (7 listed)
- other neurological diseases
- cardiological diseases
- underwent surgery
- severe joint pain
- alcoholism
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 |
|---|---|---|
| NeurorehabilitationAlso: BPPV groupAfter examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training. | Behavioural | BPPV Epley, BPPV Optocinetic, BPPV intervention |
Primary outcome
EQ5D-5L
Time frame: 5 weeks
Quality of life testing is taken with a test. The therapist scores the answers to the questions asked on a scale. The end result determines the quality of life.
Beam Walking test
Time frame: 5 weeks
The patient walks on slats of varying width. During the examination, the therapist says the tasks (Eg: counting backwards). The study detects the determination of dynamic equilibrium.
Posturography
Time frame: 5 weeks
Noninvasive intervention where static equilibrium is examined. The program determines the quality and frequency of the displacements.
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 14 Jan 2021.
- BPPV rehabilitationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Postural Vertigo
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Stroke
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A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Chronic Dizziness, Persistent Postural Perceptual Dizziness
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Using Glialia for Treating Persistent Perceptual Postural Dizziness
Persistent Postural Perceptual Dizziness
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Prevalence and Diagnosis of Persistent Postural-perceptual Dizziness
Persistent Postural-perceptual Dizziness
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 Neurorehabilitation in people with Postural Vertigo and Vertigo, Paroxysmal, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 7 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 14 Jan 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 Hungary. 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?
EQ5D-5L (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2021.