Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acute balance compensation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Acute balance compensation
时间窗: 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).
次要结局
- 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)
- Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term(One month after surgery)
- Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term(Three months after surgery)
- Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term(One year after surgery)
- Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)(One week after surgery)
- Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term(One month after surgery)
- Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term(Three months after surgery)
- Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term(One year after surgery)
- Acute change in vestibular function(One week after surgery)
- Change in vestibular function at short term(One month after surgery)
- Change in vestibular function at middle term(Three months after surgery)
- Change in vestibular function at long term(One year after surgery)
- Preoperative change in vestibular function(From baseline to three days before surgery)
研究者
Cecile PARIETTI-WINKLER
University Professor - Hospital Practitioner
Central Hospital, Nancy, France