Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sensory Organization Test Score at Post-Treatment Assessments
研究概览
简要总结
The study is a pilot efficacy study. The investigators aim to estimate mean baseline and post-treatment balance scores among Vestibular Schwannomas (VS) patients undergoing pretreatment rehab (PREHAB) or no PREHAB when managed with either surgery or radiosurgery.
详细描述
Study Design: This is a pilot randomized study with enrollment of 9 patients each to 4 groups: PREHAB+Surgery, No PREHAB+Surgery, PREHAB+Radiosurgery, and No PREHAB+Radiosurgery. Eighteen patients will be enrolled to receive each treatment type: surgery and radiosurgery. Within each type, patients will be randomized to PREHAB or NO PREHAB at a 1:1 ratio using stratified permuted blocks. The treatment modality will be determined by the patient and investigator(s) based upon collective consultations with neuro-otology, neurosurgery, and radiation oncology aligned with the Medical College of Wisconsin sporadic VS treatment guidelines.
Study Intervention: A PREHAB visit will be done once weekly for three weeks to determine exercise regimen prior to surgery or radiotherapy. Therapy includes balance exercises (twice daily), gaze stabilization exercises (12-20 minutes daily), and habituation exercises (as applicable). Standard surgical approaches including retrosigmoid, translabyrinthine, and middle fossa and radiosurgical (SRS) delivery will be determined based on current VS management guidelines and followed by study randomization to PREHAB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Male or female participants ≥18 years of age.
- •Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice
- •VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS
- •Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- •Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator
- •Be willing to adhere to outlined study protocol criteria and complete self-reported questionnaires (translations may be made available if the patient' primary language is not English).
- •For females of reproductive potential: must have a negative urine or serum pregnancy test 7 prior to enrollment and agreement to use of highly effective contraception method during study participation and for an additional 24 weeks after the completion of stereotactic radiosurgery.
排除标准
- •Subjects less than 18 years of age
- •Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure
- •Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
- •Other medical comorbidities know to significantly impair/affect balance and/or vestibular function testing (e.g., prior stroke, uncorrected visual impairment or blindness, etc.)
- •Anticipated radiation other than stereotactic (fractionated)
- •Inability to undergo MRI scans safely
- •Allergy to Gadolinium contrast used for MRI scans
- •Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of study related treatment and additional 24 weeks following stereotactic radiosurgery administration.
结局指标
主要结局
Sensory Organization Test Score at Post-Treatment Assessments
时间窗: Post-treatment 12 months
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
时间窗: Post-treatment 1 week
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
时间窗: Post-treatment 6 weeks
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
时间窗: Post-treatment six months
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
次要结局
未报告次要终点
研究者
Michael Harris
Assistant Professor
Medical College of Wisconsin