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Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation

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ClinicalTrials.gov Identifier: NCT03553264
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
University of Rome Tor Vergata
Information provided by (Responsible Party):
Uniter Onlus

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
Otoneurological Test [ Time Frame: one month ]
Study of vestibulo-ocular reflex VOR) by means of vHIT measuring its gain as the ratio between head and eye velocity. Low VOR gain values (range: 0.8-1) indicate low levels of activity of the semicircular canal.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • Balance Test [ Time Frame: one month ]
    Study of the surface of the ellipse of confidence (mm) by means of static posturography platform will be used to assess the sway of the posture. Low levels of outcomes indicate better performances. No specific reference ranges are given in literature.
  • Self-report dizziness handicap [ Time Frame: one month ]
    The Italian Dizziness Handicap Inventory (DHI) wil be used to assess the self-report dizziness handicap. It consists of 25 questions designed to assess a patient's functional (nine questions), emotional (nine questions), and physical (seven questions) limitations; scores range from 0 to 100, with moderate and severe disability usually associated with scores above 30 and 60, respectively
  • Balance Confidence [ Time Frame: one month ]
    The Activities-specific Balance Confidence scale will be used to record the patient's perceived level of balance confidence during 16 everyday activities ranging from 0 to 100%. Higher values are referred to better balance confidence. No cut-off are given in literature.
  • Gait [ Time Frame: one month ]
    The Dynamic Gait Index will examin the patient's ability to perform various gait activities on an eight-item scale; range is from 0 to 24, with scores less than 19 indicating increased risk of falls.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
Official Title  ICMJE Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial
Brief Summary

The aim of the present study will be to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Main outcomes will be: otoneurological testing (vestibulo-ocular reflex gain study by means of vHIT and posturography measures with particular attention on power spectra) and self-report and performance measures (DHI, DGI and ABC). Side effects of HMD implementation will be studied by means of Simulator Sickness Questionnaires.

Moreover, second part of the study would collect patients' data one year after the end of the vestibular rehabilitation or its implementation with HMD.

Detailed Description

Due to the recent outbreak of virtual reality in the field of rehabilitation, the use of head-mounted devices has been proposed in addition to conventional vestibular rehabilitation therapy in unilateral vestibular hypofunction patients. This approach has been proved to be useful in maximizing vestibular rehabilitation outcomes, with minimum simulator-related side effects. Virtual reality-based devices have been tested in vestibular rehabilitation by many clinicians, due to the possibility of achieving habituation, substitution and adaptation, the effectiveness in people presenting visual vertigo, and the positive effects on anxiety.

Thus, due to the undeniable relevance of testing outcomes of vestibular rehabilitation, and the promising results of head-mounted device-based home exercises in ameliorating its effects, the aim of this study will be to compare - in terms of short- (one week) and long-term (one year) effects - the subjective and objective indicators of vestibular function in a population of patients with unilateral vestibular hypofunction after completing conventional vestibular rehabilitation therapy with a randomized group who underwent a mixed-methods protocol including vestibular rehabilitation and head-mounted device treatment over the same period of time.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Diseases
  • Virtual Rehabilitation
Intervention  ICMJE
  • Device: Virtual Reality Rehabilitation
    Track Speed Racing 3D game will run with HMD 'Revelation' 3D VR Headset and each HMD group patient will be instructed to perform the game protocol uninterruptedly for 20min/day, while sitting on a chair or sofa.
  • Other: Vestibular Rehabilitation
    The home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises
Study Arms  ICMJE
  • Experimental: Head Mounted Device
    In addition to the Vestibular Rehabilitation protocol, each HMD group patient will perform Virtual Reality Rehabilitation by means of the game protocol "Track Speed Racing 3D" uninterruptedly for 20min/day, while sitting on a chair or sofa, after the smartphone accommodation into the HMD 'Revelation' 3D VR Headset. The game consists of a point-of-view race in which the car is steered from the cockpit by tilting the head to the left and to the right to avoid swerving off the road and to achieve all the goals before finishing the lap. During this real car experience, the visual background and the scenario change perspective according to the patients' left or right tilted head movements, possibly emulating eye-head exercises that induce visual-vestibular conflicts.
    Interventions:
    • Device: Virtual Reality Rehabilitation
    • Other: Vestibular Rehabilitation
  • Active Comparator: Vestibular Rehabilitation
    Patients will be actively involved in adapting the exercise program to suit their symptoms, capabilities, and lifestyle. Following previous protocols, the home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises, and all chronic unilateral vestibular hypofunction patients will be seen twice a week for 4 weeks for 30-45 min and monitored for adherence. Between supervised sessions, patients will perform a twice-daily home exercise program for a total of 30-40min/day.
    Intervention: Other: Vestibular Rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- right-handed patients affected by right chronic Unilateral Vestibular Hypofunction, the diagnosis of which will be achieved with at least 25% reduced vestibular response at bithermal water caloric irrigations on one side when calculated by means of Jongkees' formula after at least 3 months from the onset of symptoms.

Exclusion Criteria:

  • negative anamnesis for malignancy,
  • negative anamnesis for head trauma,
  • negative anamnesis for neuropsychiatric disorders
  • negative anamnesis for metabolic diseases
  • negative anamnesis for cardiovascular diseases
  • negative anamnesis for endocrine diseases
  • treatment with drugs possibly impacting on auditory and visuo-vestibular functions
  • negative anamnesis for infectious diseases
  • negative anamnesis for otoneurological diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alessandro Micarelli, M.D.,Ph.D. 0039-3356222157 alessandromicarelli@yahoo.it
Contact: Fausto Gandini 0039-0774302122 amministrazioneuniter@gmail.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553264
Other Study ID Numbers  ICMJE UniterHMD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Uniter Onlus
Study Sponsor  ICMJE Uniter Onlus
Collaborators  ICMJE University of Rome Tor Vergata
Investigators  ICMJE
Principal Investigator: Alessandro Micarelli, M.D.,Ph.D. Uniter Onlus
PRS Account Uniter Onlus
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP