Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

Vestibular Schwannoma Clinical Trial

— ReveSTAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275325
• Other study ID #: 2014-A01189-38
• Secondary ID: 140989B-31
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: June 20, 2016
• Start date: January 2015
• Est. completion date: April 2019

Study information

• Verified date: June 2016
• Source: Central Hospital, Nancy, France
• Contact: Cécile Parietti-Winkler, MD, PhD
• Phone: +33 383 852 032
• Email: c.parietti[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Other:
• Preoperative vestibular rehabilitation
12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)

Locations

Country	Name	City	State
France	University Hospital of Nancy	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No