Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

NCT ID: NCT02275325

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vestibular Schwannoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative rehabilitation

Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation

Group Type EXPERIMENTAL

Preoperative vestibular rehabilitation

Intervention Type OTHER

12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)

Usual

Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative vestibular rehabilitation

12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Cecile PARIETTI-WINKLER

University Professor - Hospital Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cécile Parietti-Winkler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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University Hospital of Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: CONTACT

+33 383 852 032

Gérome Gauchard, PhD

Role: CONTACT

Facility Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: primary

+33 383 852 032

Gérome Gauchard, PhD

Role: backup

Other Identifiers

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140989B-31

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A01189-38

Identifier Type: -

Identifier Source: org_study_id

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