Clinical trial NCT03553264: Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
Official title: Impact of Home-based Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation Protocols: a Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Diseases
Virtual Rehabilitation
Lead sponsor: Uniter Onlus
Sponsor class: OTHER
Collaborators: name: University of Rome Tor Vergata
First posted: 2018-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Otoneurological Test
timeFrame: one month
Secondary outcomes:
measure: Balance Test
timeFrame: one month
measure: Self-report dizziness handicap
timeFrame: one month
measure: Balance Confidence
timeFrame: one month
measure: Gait
timeFrame: one month
Other outcomes:
Locations:
city: Guidonia
country: Italy
facility: UNITER ONLUS for balance and rehabilitation research
state: Rome
Study officials:
affiliation: Uniter Onlus
name: Alessandro Micarelli, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.