Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

Not Applicable

• Conditions: Vestibular Schwannoma
• Interventions: Other: Preoperative vestibular rehabilitation

• Registration Number: NCT02275325
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Study Start: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21
• Primary Completion: 2018-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative rehabilitation	Preoperative vestibular rehabilitation	Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation

Primary Outcome Measures

Name	Time	Method
Acute balance compensation	One week after surgery	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).

Secondary Outcome Measures

Name	Time	Method
Balance compensation at short term	One month after surgery	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).
Balance compensation at middle term	Three months after surgery	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).
Balance compensation at long term	One year after surgery	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).
Preoperative balance compensation	From baseline to three days before surgery	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).
Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)	One week after surgery	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).
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term	One month after surgery	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).
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term	Three months after surgery	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).
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term	One year after surgery	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).
Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)	One week after surgery	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).
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term	One month after surgery	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).
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term	Three months after surgery	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).
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term	One year after surgery	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).
Acute change in vestibular function	One week after surgery	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).
Change in vestibular function at short term	One month after surgery	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).
Change in vestibular function at middle term	Three months after surgery	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).
Change in vestibular function at long term	One year after surgery	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).
Preoperative change in vestibular function	From baseline to three days before surgery	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).

Trial Locations

Locations (1)

University Hospital of Nancy; 🇫🇷 Nancy, France