Clinical trial NCT02275325: Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery
Official title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Schwannoma
Keywords: Posture
Unilateral vestibular deafferentation
Medical management
Preoperative vestibular rehabilitation
Neural plasticity
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2014-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute balance compensation
timeFrame: One week after surgery
Secondary outcomes:
measure: Balance compensation at short term
timeFrame: One month after surgery
measure: Balance compensation at middle term
timeFrame: Three months after surgery
measure: Balance compensation at long term
timeFrame: One year after surgery
measure: Preoperative balance compensation
timeFrame: From baseline to three days before surgery
measure: Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)
timeFrame: One week after surgery
measure: Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term
timeFrame: One month after surgery
measure: Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term
timeFrame: Three months after surgery
measure: Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term
timeFrame: One year after surgery
measure: Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)
timeFrame: One week after surgery
measure: Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term
timeFrame: One month after surgery
measure: Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term
timeFrame: Three months after surgery
measure: Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term
timeFrame: One year after surgery
measure: Acute change in vestibular function
timeFrame: One week after surgery
measure: Change in vestibular function at short term
timeFrame: One month after surgery
measure: Change in vestibular function at middle term
timeFrame: Three months after surgery
measure: Change in vestibular function at long term
timeFrame: One year after surgery
measure: Preoperative change in vestibular function
timeFrame: From baseline to three days before surgery
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Hospital of Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Cécile Parietti-Winkler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: