Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)
Primary Purpose
Vestibular Schwannoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preoperative vestibular rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Schwannoma focused on measuring Posture, Unilateral vestibular deafferentation, Medical management, Preoperative vestibular rehabilitation, Neural plasticity
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
Sites / Locations
- University Hospital of NancyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preoperative rehabilitation
Usual
Arm Description
Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation
Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT02275325
First Posted
October 17, 2014
Last Updated
June 20, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT02275325
Brief Title
Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery
Acronym
ReveSTAN
Official Title
Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Posture, Unilateral vestibular deafferentation, Medical management, Preoperative vestibular rehabilitation, Neural plasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative rehabilitation
Arm Type
Experimental
Arm Description
Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation
Arm Title
Usual
Arm Type
No Intervention
Arm Description
Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery
Intervention Type
Other
Intervention Name(s)
Preoperative vestibular rehabilitation
Intervention Description
12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)
Primary Outcome Measure Information:
Title
Acute balance compensation
Description
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).
Time Frame
One week after surgery
Secondary Outcome Measure Information:
Title
Balance compensation at short term
Description
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).
Time Frame
One month after surgery
Title
Balance compensation at middle term
Description
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).
Time Frame
Three months after surgery
Title
Balance compensation at long term
Description
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).
Time Frame
One year after surgery
Title
Preoperative balance compensation
Description
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).
Time Frame
From baseline to three days before surgery
Title
Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)
Description
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).
Time Frame
One week after surgery
Title
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term
Description
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).
Time Frame
One month after surgery
Title
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term
Description
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).
Time Frame
Three months after surgery
Title
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term
Description
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).
Time Frame
One year after surgery
Title
Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)
Description
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).
Time Frame
One week after surgery
Title
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term
Description
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).
Time Frame
One month after surgery
Title
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term
Description
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).
Time Frame
Three months after surgery
Title
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term
Description
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).
Time Frame
One year after surgery
Title
Acute change in vestibular function
Description
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).
Time Frame
One week after surgery
Title
Change in vestibular function at short term
Description
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).
Time Frame
One month after surgery
Title
Change in vestibular function at middle term
Description
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).
Time Frame
Three months after surgery
Title
Change in vestibular function at long term
Description
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).
Time Frame
One year after surgery
Title
Preoperative change in vestibular function
Description
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).
Time Frame
From baseline to three days before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Parietti-Winkler, MD, PhD
Phone
+33 383 852 032
Email
c.parietti@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gérome Gauchard, PhD
Email
gerome.gauchard@univ-lorraine.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Parietti-Winkler, MD, PhD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Parietti-Winkler, MD, PhD
Phone
+33 383 852 032
Email
c.parietti@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Gérome Gauchard, PhD
Email
gerome.gauchard@univ-lorraine.fr
First Name & Middle Initial & Last Name & Degree
Philippe Perrin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean Paysant, MD, PhD
First Name & Middle Initial & Last Name & Degree
Benoîte Lassalle-Kinic, MD
12. IPD Sharing Statement
Learn more about this trial
Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery
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