Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 12, 2018
May 1, 2018
1.7 years
May 16, 2018
May 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Balance Test
one month
Self-report dizziness handicap
one month
Balance Confidence
one month
Gait
one month
Study Arms (2)
Head Mounted Device
EXPERIMENTALIn 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.
Vestibular Rehabilitation
ACTIVE COMPARATORPatients 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.
Interventions
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.
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
You may qualify if:
- \- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uniter Onluslead
- University of Rome Tor Vergatacollaborator
Study Sites (1)
UNITER ONLUS for balance and rehabilitation research
Guidonia, Rome, 00012, Italy
Related Publications (2)
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.
PMID: 26556560BACKGROUNDAlahmari 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.
PMID: 24608691RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Micarelli, M.D.,Ph.D.
Uniter Onlus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2018
First Posted
June 12, 2018
Study Start
August 1, 2016
Primary Completion
May 1, 2018
Study Completion
December 1, 2018
Last Updated
June 12, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share