Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

NCT02275325 | Unknown DMC

• 2 other identifiers: 2014-A01189-38140989B-31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Posture; Unilateral vestibular deafferentation; Medical management; Preoperative vestibular rehabilitation; Neural plasticity

Outcome Measures

Primary Outcomes (1)

• Acute balance compensation

  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).

  One week after surgery

Secondary Outcomes (17)

• Balance compensation at short term

  One month after surgery

• Balance compensation at middle term

  Three months after surgery

• Balance compensation at long term

  One year after surgery

• Preoperative balance compensation

  From baseline to three days before surgery

• Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)

  One week after surgery

Study Arms (2)

Preoperative rehabilitation

EXPERIMENTAL

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

Other: Preoperative vestibular rehabilitation

Usual

NO INTERVENTION

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

Interventions

Preoperative vestibular rehabilitation OTHER

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

Preoperative rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Study Sites (1)

University Hospital of Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; 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

Study Officials

• Cécile Parietti-Winkler, MD, PhD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Parietti-Winkler, MD, PhD

CONTACT

+33 383 852 032; c.parietti@chu-nancy.fr

Gérome Gauchard, PhD

CONTACT

gerome.gauchard@univ-lorraine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor - Hospital Practitioner

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 27, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

FR (1)