Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation

Vestibular Diseases Clinical Trial

Official title:

Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553264
• Other study ID #: UniterHMD
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Uniter Onlus
• Contact: Alessandro Micarelli, M.D.,Ph.D.
• Phone: 0039-3356222157
• Email: alessandromicarelli[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases
• Virtual Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Italy	UNITER ONLUS for balance and rehabilitation research	Guidonia	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Uniter Onlus	University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Alahmari KA, Sparto PJ, Marchetti GF, Redfern MS, Furman JM, Whitney SL. Comparison of virtual reality based therapy with customized vestibular physical therapy for the treatment of vestibular disorders. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2): — View Citation

Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. Epub 2015 Apr 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Otoneurological Test	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.	one month
Secondary	Balance Test	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.	one month
Secondary	Self-report dizziness handicap	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	one month
Secondary	Balance Confidence	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.	one month
Secondary	Gait	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.	one month