Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
NCT ID: NCT03553264
Last Updated: 2018-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-08-31
2018-12-31
Brief Summary
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Moreover, second part of the study would collect patients' data one year after the end of the vestibular rehabilitation or its implementation with HMD.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Uniter Onlus
OTHER
Responsible Party
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Principal Investigators
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Alessandro Micarelli, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Uniter Onlus
Locations
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UNITER ONLUS for balance and rehabilitation research
Guidonia, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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):389-99. doi: 10.1109/TNSRE.2013.2294904.
Other Identifiers
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UniterHMD
Identifier Type: -
Identifier Source: org_study_id
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