Clinical Trial 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.
