Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)

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

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.

Study Overview

• Status: Unknown
• Conditions: Vestibular Schwannoma
• Intervention / Treatment: Other: Preoperative vestibular rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile Parietti-Winkler, MD, PhD; Phone Number: +33 383 852 032; Email: c.parietti@chu-nancy.fr
• Study Contact Backup: Name: Gérome Gauchard, PhD; Email: gerome.gauchard@univ-lorraine.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • University Hospital Of Nancy
    • Contact: Cécile Parietti-Winkler, MD, PhD; Phone Number: +33 383 852 032; Email: c.parietti@chu-nancy.fr
    • Contact: Gérome Gauchard, PhD; Email: gerome.gauchard@univ-lorraine.fr
    • Sub-Investigator: Philippe Perrin, MD, PhD
    • Sub-Investigator: Jean Paysant, MD, PhD
    • Sub-Investigator: Benoîte Lassalle-Kinic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University of Lorraine
• Investigators: Principal Investigator: Cécile Parietti-Winkler, MD, PhD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Posture; Medical management; Neural plasticity; Unilateral vestibular deafferentation; Preoperative vestibular rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: 2014-A01189-38; 140989B-31 (Other Identifier: ANSM)