Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

Study Overview
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Brief Summary
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Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation. Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.

Detailed Description
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To test this hypothesis, the measured and perceived balance control of the patient and the quality of life will be assessed into two groups: one of two groups will receive preoperative vestibular rehabilitation, carried out by a physiotherapist, and the other not. The assessments will be conducted 45 days and 3 days before surgery, and then 8 days, 30 days, 90 days and 365 days after surgery.

Official Title
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Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery

Conditions
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Vestibular Schwannoma

Intervention / Treatment
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* Other: Preoperative vestibular rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery. Patients gave their written informed consent Patients are affiliated to the french social welfare Exclusion Criteria: Disorders from the motor and/or somesthetic systems (especially the lower limbs) Contraindications to the scheduled functional assessments: ear pathology different from vestibular schwannoma such as cholesteatoma of the middle ear, tympanic membrane perforation, etc. Refusal of the surgical procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative rehabilitation<br>Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation | Other: Preoperative vestibular rehabilitation<br>* 12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)<br>|
| No Intervention: Usual<br>Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute balance compensation | Change in composite equilibrium score from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual). | One week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance compensation at short term | Change in composite equilibrium score from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual). | One month after surgery | 
| Balance compensation at middle term | Change in composite equilibrium score from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual). | Three months after surgery | 
| Balance compensation at long term | Change in composite equilibrium score from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual). | One year after surgery | 
| Preoperative balance compensation | Change in composite equilibrium score from baseline to three days before surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual). | From baseline to three days before surgery | 
| Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory) | Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One week after surgery | 
| Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term | Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One month after surgery | 
| Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term | Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | Three months after surgery | 
| Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term | Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One year after surgery | 
| Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) | Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One week after surgery | 
| Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term | Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One month after surgery | 
| Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term | Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | Three months after surgery | 
| Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term | Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation. Comparison between both groups (preoperative rehabilitation vs. usual). | One year after surgery | 
| Acute change in vestibular function | Change in vestibular function (measured by means of videonystagmography) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests. Comparison between both groups (preoperative rehabilitation vs. usual). | One week after surgery | 
| Change in vestibular function at short term | Change in vestibular function (measured by means of videonystagmography) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests. Comparison between both groups (preoperative rehabilitation vs. usual). | One month after surgery | 
| Change in vestibular function at middle term | Change in vestibular function (measured by means of videonystagmography) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests. Comparison between both groups (preoperative rehabilitation vs. usual). | Three months after surgery | 
| Change in vestibular function at long term | Change in vestibular function (measured by means of videonystagmography) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests. Comparison between both groups (preoperative rehabilitation vs. usual). | One year after surgery | 
| Preoperative change in vestibular function | Change in vestibular function (measured by means of videonystagmography) from baseline to three days before surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests. Comparison between both groups (preoperative rehabilitation vs. usual). | From baseline to three days before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posture, Unilateral vestibular deafferentation, Medical management, Preoperative vestibular rehabilitation, Neural plasticity