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

Summary

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

Conditions

• Benign Paroxysmal Positional Vertigo

Interventions

DEVICE

Automated vertigo repositioning chair

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). 1. Dix-Hallpike (for posterior canal involvement) 2. Supine roll (for horizontal canal involvement) 3. (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). 1. Epley's and/or Semont's maneuver (for posterior canal involvement) 2. Barbecue and/or Gufoni's maneuver (for horizontal canal involvement) 3. 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.

OTHER

Canalith Reposition Maneuver

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: 1. Dix-Hallpike (for posterior canal involvement) 2. 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: 1. Epley's maneuver (for posterior canal involvement) 2. 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.

Sponsors & Collaborators

• Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

  collaborator UNKNOWN

• Stratejik Yenilikci Girisimler Ltd.

  lead INDUSTRY

Principal Investigators

• Murat H Ozkul, M.D. · StatejikYG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-15

Primary Completion

2022-04-12

Completion

2022-04-23

Countries

• Turkey (Türkiye)

Study Locations