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Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery (ReveSTAN)

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Vestibular Schwannoma

Treatments

Other: Preoperative vestibular rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02275325
140989B-31 (Other Identifier)
2014-A01189-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Preoperative rehabilitation
Experimental group
Description:
Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation
Treatment:
Other: Preoperative vestibular rehabilitation
Usual
No Intervention group
Description:
Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery

Trial contacts and locations

1

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Central trial contact

Cécile Parietti-Winkler, MD, PhD; Gérome Gauchard, PhD

Data sourced from clinicaltrials.gov

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