Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.

NCT ID: NCT03838562

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2024-03-04

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.

Conditions

Vestibular Syndrome; Optokinetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Arm

Group Type: EXPERIMENTAL

Vestibular rehabilitation with virtual reality

Intervention Type: 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.

Control Arm

Group Type: ACTIVE_COMPARATOR

Standard optokinetic stimulator or dynamic visual surround

Intervention Type: 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.

Interventions

Vestibular rehabilitation with virtual reality

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.

Intervention Type: OTHER

Standard optokinetic stimulator or dynamic visual surround

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy

Lamalou-les-Bains, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 40253374 (View on PubMed)

Other Identifiers

2018-A02247-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL18_0243

Identifier Type: -

Identifier Source: org_study_id