Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Condition: Benign Paroxysmal Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Automated vertigo repositioning chair; Canalith Reposition Maneuver
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Other intervention name(s): Robotic Maneuvering System (RMS); Manual Reposition Maneuver
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Automated; Robotic; Vertigo; Epley maneuver; RMS chair; Reposition chair; Dizziness; Vestibular diseases; Multi canal BPPV