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

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

Detailed Description
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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.

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

Conditions
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Benign Paroxysmal Positional Vertigo

Intervention / Treatment
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* Device: Automated vertigo repositioning chair
* Other: Canalith Reposition Maneuver


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients previously diagnosed with BPPV were referred to vestibular laboratory at the Department of Otolaryngology at Haseki Sultangazi Teaching and Research Hospital. Videonystagmography was performed on all subjects to confirm the BPPV diagnosis. Patients were then randomly divided into two groups; experimental and control. The experimental group was treated with RMS, while control group was treated with traditional manual canalith repositioning maneuvers on an examination table.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Maneuvering System (RMS)<br>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. | Device: Automated vertigo repositioning chair<br>* Patients are strapped to the chair with a safety harness, and video fenzel goggle are worn. Automated diagnostic procedures are performed to determine vertigo subtype and orientation (Left/Right) (described below). Dix-Hallpike (for posterior canal involvement) Supine roll (for horizontal canal involvement) (Optional) Deep Head Hanging (for anterior canal involvement) If nystagmus is detected during automated diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding automated treatment maneuver will be performed (described below). Epley's and/or Semont's maneuver (for posterior canal involvement) Barbecue and/or Gufoni's maneuver (for horizontal canal involvement) Yacovino's maneuver (for anterior canal involvement) 10 minutes after performing automated treatment maneuver, provocative diagnostic test maneuver was performed once again to ensure successful intervention. A follow-up was done one week later at the earliest.<br>* Other names: Robotic Maneuvering System (RMS);|
| Active Comparator: Canalith Reposition Maneuver<br>BPPV subtype diagnosis and corresponding treatment will be performed with manual repositioning maneuvers and recorded with video frenzel goggle. In cases of posterior canal involvement, Epley's maneuver will be used. In cases of horizontal canal involvement, Log roll maneuver will be used. In cases of anterior canal involvement, Yacovino's maneuver will be used. | Other: Canalith Reposition Maneuver<br>* Patients were seated on a examination table and given videonystagmography goggles (VNG). Manual diagnostic procedures are performed to determine vertigo subtype and orientation. The manual diagnostic procedures for Left and Right sided semicircular canals are: Dix-Hallpike (for posterior canal involvement) Supine roll and Bow and Lean (for horizontal canal involvement) If nystagmus is detected during diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding treatment maneuvers will be performed manually. The automated treatment maneuvers are: Epley's maneuver (for posterior canal involvement) Barbecue and/or Gufoni's maneuver (for horizontal canal involvement) Patients were called back for a follow up 2 days after performing manual treatment maneuvers. Provocative diagnostic testing maneuvers were performed again to ensure successful intervention. A second follow-up was done one week later at the earliest.<br>* Other names: Manual Reposition Maneuver;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatments | Number of treatment necessary to achieve resolution of vertigo and nystagmus | 1 month (30 days) | 
| Treatment success | Number of subjects achieving resolution of vertigo and nystagmus after one treatment | After treatment: 1 week - 1 month (30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo-Dizziness Imbalance (VDI) questionnaire | Comparison of pre-treatment and post-treatment score based on symptoms and quality of life | 1 month (30 days) | 
| Adverse events | Registration of adverse events and safety issues related to RMS. | 1 month (30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases, Multi canal BPPV