Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.
- Conditions
- Vestibular SyndromeOptokinetic Stimulation
- Interventions
- Other: Standard optokinetic stimulator or dynamic visual surroundOther: Vestibular rehabilitation with virtual reality
- Registration Number
- NCT03838562
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Standard optokinetic stimulator or dynamic visual surround - Virtual Reality Arm Vestibular rehabilitation with virtual reality -
- Primary Outcome Measures
Name Time Method Balance score with eyes closed on an unstable plane during a sensory organization test after 3 or 4 weeks of rehabilitation Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
- Secondary Outcome Measures
Name Time Method The Dizziness Handicap Inventory 4 month The Simulator Sickness Questionnaire weekly from week 1 to week 3 or 4 This questionnaire includes the following questions: "Not at all", "A little", "Moderately" and "Severely", each answer is worth 0, 1, 2 or 3 points. The total score is equal to 48, the two scores are calculable "Nausea" on 27 and "Oculomotor" on 21. The higher the score, the more the side effects are important.l 10 minutes
Others score of the sensory organization test 3 or 4 weeks Realized with the Framiral® multitest equilibre.Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
Trial Locations
- Locations (1)
CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy
🇫🇷Lamalou-les-Bains, France