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Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)

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ClinicalTrials.gov Identifier: NCT02275325
Recruitment Status : Unknown
Verified June 2016 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date June 21, 2016
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
Acute balance compensation [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02275325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Balance compensation at short term [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery
Official Title  ICMJE Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vestibular Schwannoma
Intervention  ICMJE Other: Preoperative vestibular rehabilitation
12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)
Study Arms  ICMJE
  • Experimental: Preoperative rehabilitation
    Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation
    Intervention: Other: Preoperative vestibular rehabilitation
  • No Intervention: Usual
    Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02275325
Other Study ID Numbers  ICMJE 2014-A01189-38
140989B-31 ( Other Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE University of Lorraine
Investigators  ICMJE
Principal Investigator: Cécile Parietti-Winkler, MD, PhD Central Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP