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Trial record 3 of 36 for:    Schwannoma | Recruiting, Not yet recruiting, Available Studies

Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)

This study is currently recruiting participants.
Verified June 2016 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02275325
First Posted: October 27, 2014
Last Update Posted: June 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
  Purpose

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.


Condition Intervention
Vestibular Schwannoma Other: Preoperative vestibular rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery

Resource links provided by NLM:


Further study details as provided by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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).



Estimated Enrollment: 50
Study Start Date: January 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275325


Contacts
Contact: Cécile Parietti-Winkler, MD, PhD +33 383 852 032 c.parietti@chu-nancy.fr
Contact: Gérome Gauchard, PhD gerome.gauchard@univ-lorraine.fr

Locations
France
University Hospital of Nancy Recruiting
Nancy, France, 54000
Contact: Cécile Parietti-Winkler, MD, PhD    +33 383 852 032    c.parietti@chu-nancy.fr   
Contact: Gérome Gauchard, PhD       gerome.gauchard@univ-lorraine.fr   
Sub-Investigator: Philippe Perrin, MD, PhD         
Sub-Investigator: Jean Paysant, MD, PhD         
Sub-Investigator: Benoîte Lassalle-Kinic, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
University of Lorraine
Investigators
Principal Investigator: Cécile Parietti-Winkler, MD, PhD Central Hospital, Nancy, France
  More Information

Responsible Party: Cecile PARIETTI-WINKLER, University Professor - Hospital Practitioner, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02275325     History of Changes
Other Study ID Numbers: 2014-A01189-38
140989B-31 ( Other Identifier: ANSM )
First Submitted: October 17, 2014
First Posted: October 27, 2014
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France:
Posture
Unilateral vestibular deafferentation
Medical management
Preoperative vestibular rehabilitation
Neural plasticity

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases