Clinical Trial: Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery

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.


Detailed Summary: 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.
Sponsor: Central Hospital, Nancy, France

Current Primary Outcome: 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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 que

    Original Secondary Outcome: Same as current

    Information By: Central Hospital, Nancy, France

    Dates:
    Date Received: October 17, 2014
    Date Started: January 2015
    Date Completion: April 2019
    Last Updated: June 20, 2016
    Last Verified: June 2016