- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367194
Objective Examination and Rehabilitation Treatment of Patients With BPPV
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Somogy
-
Kaposvár, Somogy, Hungary, 7400
- Somogy Megyei Kaposi Mor Oktato Korhaz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- For a patient with BPPV
- With a lack of coordination
- Dizziness
- Ear nose laryngeal examination
- Neurological examination
Exclusion Criteria:
- other neurological diseases
- cardiological diseases
- underwent surgery
- severe joint pain
- alcoholism
- dementia
- drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BPPV intervention
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.
|
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.
Other Names:
|
Experimental: BPPV Epley
Only Epley training.
|
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.
Other Names:
|
Experimental: BPPV Optocinetic
Only Optocinetic training.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 weeks
|
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.
|
5 weeks
|
Posturography
Time Frame: 5 weeks
|
Noninvasive intervention where static equilibrium is examined.
The program determines the quality and frequency of the displacements.
|
5 weeks
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKEB2019/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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