Clinical trial NCT03838562: Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.
Official title: Non-inferiority of Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes. Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Syndrome
Optokinetic Stimulation
Keywords: virtual reality
vestibular
balance
rehabilitation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. The technology of three-dimensional head-mounted provides a strong immersion allowing optokinetic stimulation but studies interested in virtual reality in the context of balance rehabilitation have not been able to highlight the superiority of this therapy. The investigators therefore propose a non-inferiority trial because of the affordable price and small size of three-dimensional head-mounted.

Objectives : The objective of this study is to evaluate whether a rehabilitation program using virtual reality is as effective as a reference program using Smart Equitest and an optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or 4 weeks of rehabilitation.

The investigators also assess the disability related to vertigo and balance disorders as well as the tolerance of virtual reality Methodology: Prospective, randomized controlled non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of follow-up.

The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program and the possible standing position.

The criteria for non-inclusion are visually impaired or blind subjects, lack of relief vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes and Ménière's disease.

The main evaluation criterion is the balance score obtained with eyes closed on an unstable plane during a sensory organization test performed on a dynamic posturology platform, obtained during the final evaluation.

The secondary judgment criteria are:

* The balance scores obtained in the sensory organization test under other conditions.
* The Dizziness Handicap Inventory obtained during the final evaluation and three months after the end of the program.
* The tolerance of virtual reality will be measured weekly by the Simulator Sickness Questionnaire.

Statistics: The number of subjects to be included is 76, the analysis will first be performed per-protocol, the difference in scores between the two groups will be calculated, as well as its 95% confidence interval. If the lower bound of this interval is above the non-inferiority threshold, the same analysis will be performed on the population intending to treat (all randomized patients).

Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of inclusions is 27 months, The duration of patient participation in the protocol is 4 months. Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste Floret has the human and material resources necessary to carry out the protocol. The PMSI data show that the department receives about 40 patients per year who are likely to participate in the protocol.

Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual reality, this study could provide further evidence of the value of this type of tool for the rehabilitation of subjects suffering from vestibular disorders. In addition, a medico-economic study would be possible in order to reinforce the advantages of virtual reality helmets.


Eligibility criteria: Inclusion Criteria:

* Symptomatology related to a vestibular disorder, eligible for a rehabilitation program Possible standing position
* Informed subject and having signed the informed consent form
* Major subject
* Affiliation to a social security scheme

Exclusion Criteria:

* Badly sighted or blind subject (sharpness \<1 / 10th)
* Absence of vision of the reliefs
* Strabismus important
* History of epilepsy
* General state strongly altered
* Pregnant subject
* Major protected by law
* Subject deprived of liberty

Primary outcomes:
measure: Balance score with eyes closed on an unstable plane during a sensory organization test
timeFrame: after 3 or 4 weeks of rehabilitation
Secondary outcomes:
measure: Others score of the sensory organization test
timeFrame: 3 or 4 weeks
measure: The Dizziness Handicap Inventory
timeFrame: 3 or 4 weeks
measure: The Dizziness Handicap Inventory
timeFrame: 4 month
measure: The Simulator Sickness Questionnaire
timeFrame: weekly from week 1 to week 3 or 4
Other outcomes:
Locations:
city: Lamalou-les-Bains
country: France
facility: CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy
Study officials:
References: