Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Related Clinical Trial
Serum Levels of Otolin-1 and Vitamin D in Pre- and Post-treatments of BPPV Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV) Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo Paroxysmal Positional Vertigo & Repositioning Maneuvers Benign Paroxysmal Positional Vertigo in Older Adults Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo The Influence of Vestibular Stimulation on Cardiac Autonomic Control System in Subjects With and Without BPPV Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo BPPV With CRP: Single Versus Multiple Cycles Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Different Treatments With the TRV Reposition Chair BPPV Treatment in Biaxial Rotational Chair Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV) Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program Canalith Repositioning Procedure for BPPV in Primary Care Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients Cranial Osteopathic Techniques on the Symptoms of Benign Paroxysmal Positional Vertigo The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms

Brief Title

Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Official Title

Comparison of Treatment Efficacy of Automated Robotic Maneuvering System (RMS) Reposition Chair Versus Traditional Manual Repositioning Maneuvers in Benign Paroxysmal Positional Vertigo (BPPV)

Brief Summary

      Comparison of treatment efficacy of an automated robotic maneuvering system (RMS)
      repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional
      Vertigo.
    

Detailed Description

      The standard treatments for Benign Paroxysmal Positional Vertigo (BPPV) are manual
      positioning maneuvers. This method, beyond being costly and requiring extensive training, is
      a significant burden on healthcare resources. We developed an automated robotic maneuvering
      system, hereby known as RMS, to tackle this problem. Our Clinical Investigation is two-fold;
      (1) test the safety of RMS and, (2) understand the viability of RMS for treating BPPV when
      compared to manual positioning maneuvers.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Treatments

Secondary Outcome

 Vertigo-Dizziness Imbalance (VDI) questionnaire

Condition

Benign Paroxysmal Positional Vertigo

Intervention

Automated vertigo repositioning chair

Study Arms / Comparison Groups

 Robotic Maneuvering System (RMS)
Description:  BPPV subtype diagnosis and corresponding treatment will be performed using automated RMS chair and recorded with video frenzel goggle.
In cases of posterior canal involvement, Epley's maneuver will be used for canalithiasis and cupulolithiasis. Semont maneuver will be used as a second-line treatment for cupulolithiasis, in cases of initial failure.
In cases of horizontal canal involvement, Barbecue (Lempert) maneuver will be used. If canalithiasis or cupulolithiasis is diagnosed, Gufoni's maneuver will be performed.
In cases of anterior canal involvement, Yacovino's maneuver will be used.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

75

Start Date

February 15, 2022

Completion Date

April 23, 2022

Primary Completion Date

April 12, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Characteristic positional nystagmus (for BPPV)

          -  Positive Dix-Hallpike

          -  Positive supine roll test

          -  Positive Deep Head Hanging

          -  Vertigo-Dizziness Imbalance symptom scores compatible with BPPV

        Exclusion Criteria:

          -  Pregnant patients

          -  Patients who have taken vertigo suppressing agents (Dimenhydrinate) in the last 48
             hours

          -  Patients taller than 200 cm (2.0 m)

          -  Patients who have had a cardiovascular or neurosurgical operation in the last month

          -  Patients with retinal detachment and/or glaucoma

          -  Lack of treatment cooperation
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Murat H Ozkul, M.D., , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT05352555

Organization ID

SYG-RMS-18


Responsible Party

Principal Investigator

Study Sponsor

Stratejik Yenilikci Girisimler Ltd.

Collaborators

 Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

Study Sponsor

Murat H Ozkul, M.D., Principal Investigator, StatejikYG


Verification Date

April 2022