Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)
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| ClinicalTrials.gov Identifier: NCT02275325 |
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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
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Vestibular Schwannoma | Other: Preoperative vestibular rehabilitation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| 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 |
| Study Start Date : | January 2015 |
| Estimated Primary Completion Date : | April 2018 |
| Estimated Study Completion Date : | April 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Preoperative rehabilitation
Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation
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Other: Preoperative vestibular rehabilitation
12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback) |
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No Intervention: Usual
Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery
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- 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).
- 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).
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Cécile Parietti-Winkler, MD, PhD | +33 383 852 032 | c.parietti@chu-nancy.fr | |
| Contact: Gérome Gauchard, PhD | gerome.gauchard@univ-lorraine.fr |
| 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 | |
| Principal Investigator: | Cécile Parietti-Winkler, MD, PhD | Central Hospital, Nancy, France |
| Responsible Party: | Cecile PARIETTI-WINKLER, University Professor - Hospital Practitioner, Central Hospital, Nancy, France |
| ClinicalTrials.gov Identifier: | NCT02275325 |
| Other Study ID Numbers: |
2014-A01189-38 140989B-31 ( Other Identifier: ANSM ) |
| First Posted: | October 27, 2014 Key Record Dates |
| Last Update Posted: | June 21, 2016 |
| Last Verified: | June 2016 |
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Posture Unilateral vestibular deafferentation Medical management Preoperative vestibular rehabilitation Neural plasticity |
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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 |