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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02247-48 | Registry Identifier | ID-RCB |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Arm | Experimental |
| |
| Control Arm | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular rehabilitation with virtual reality | Other | Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening. The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises. Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| Balance score with eyes closed on an unstable plane during a sensory organization test | Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises | after 3 or 4 weeks of rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Others score of the sensory organization test | Realized with the Framiral® multitest equilibre.Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises | 3 or 4 weeks |
| The Dizziness Handicap Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy | Lamalou-les-Bains | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40253374 | Derived | Le Perf G, Thebault G, Duflos C, Herman F, Cauquil-Gleizes S, Laffont I. Can virtual reality replace conventional vestibular rehabilitation tools in multisensory balance exercises for vestibular disorders? A non-inferiority study. J Neuroeng Rehabil. 2025 Apr 19;22(1):86. doi: 10.1186/s12984-025-01623-x. |
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| Standard optokinetic stimulator or dynamic visual surround | Other | Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening. The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises. Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group. |
|
| 3 or 4 weeks |
| The Dizziness Handicap Inventory | 4 month |
| The Simulator Sickness Questionnaire | 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 | weekly from week 1 to week 3 or 4 |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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