Prospective Comparative Clinical Study of Three Parallel Cohorts on the Efficacy of Pre- and Post-surgical Vestibular Rehabilitation With or Without Rotary Stimulation in Patients With Vestibular Schwannoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Video Hit Impulse Test (VHIT)
研究概览
简要总结
Brief Summary
The purpose of this clinical trial is to evaluate whether different strategies of vestibular rehabilitation, performed before and after surgery, can improve recovery in adults diagnosed with unilateral vestibular schwannoma. The main questions the study aims to answer are:
Does preoperative vestibular telerehabilitation improve postoperative vestibular compensation compared with no intervention?
Does adding preoperative rotatory chair stimulation to telerehabilitation lead to greater improvements in balance, dizziness, or hospital length of stay?
The study includes three comparison groups:
No-intervention group: Participants do not receive pre- or postoperative rehabilitation, but complete all study assessments (vHIT, DHI, posturography, and hospital length of stay).
Telerehabilitation group: Participants complete a structured home-based vestibular telerehabilitation program (ReHub) for 3 weeks before surgery and again for 3 weeks after surgery.
Rotatory Chair + Telerehabilitation group: Participants receive the same telerehabilitation program as the telerehabilitation group, plus six supervised sessions of preoperative rotatory chair stimulation (two sessions per week for three weeks), following a progressive protocol in the ENT department using a CE-marked clinical rotatory chair.
Participants will:
Attend routine preoperative and postoperative assessments (vHIT, posturography, and DHI).
Complete home-based vestibular exercises through a digital telerehabilitation platform (Groups 2 and 3).
If assigned to the Rotatory Chair + Telerehabilitation group, attend six in-hospital sessions of controlled rotatory chair stimulation during the three weeks before surgery.
Undergo follow-up evaluations at 4 and 12 weeks after surgery.
This study aims to determine whether structured vestibular training conducted before and after surgery can enhance postoperative compensation and reduce symptom burden in patients undergoing vestibular schwannoma surgery.
详细描述
This prospective, non-randomized, three-arm clinical trial evaluates the effect of two pre- and postoperative vestibular rehabilitation strategies on postoperative vestibular compensation in adults undergoing surgery for unilateral vestibular schwannoma. Aberrant vestibular compensation following vestibular neurectomy is common, and many patients experience prolonged imbalance, dizziness, altered gaze stabilization, and delayed return to functional independence. Early activation of vestibular adaptation, habituation, and substitution mechanisms may help optimize postoperative recovery.
The study compares three parallel cohorts:
a no-intervention group receiving standard clinical care,
a telerehabilitation group performing a structured home-based vestibular exercise program before and after surgery, and
an enhanced rehabilitation group receiving the same telerehabilitation program plus a progressive protocol of supervised preoperative rotatory chair stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Sequential convenience sampling approach.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Tumor size between 1.5 cm and 4 cm
- •Unilateral vestibular schwannoma
排除标准
- •Degenerative neurological conditions
- •History of cerebrovascular disease
- •Musculoskeletal deformities
研究组 & 干预措施
ARM 1 - No Intervention Group
Participants receive the standard surgical treatment for unilateral vestibular schwannoma and complete all study assessments (vHIT, DHI, posturography, hospital length of stay). They do not receive any pre- or postoperative vestibular rehabilitation.
干预措施: No Intervention: Observational Cohort (Other)
ARM 2 - Group Telerehabilitation Only
Participants complete a structured vestibular telerehabilitation program delivered through the ReHub digital platform for three weeks before surgery and for three weeks after surgery. The program includes guided home-based vestibular exercises, video instructions, activity tracking, and remote clinical supervision.
干预措施: Structured home-based vestibular telerehabilitation program (Behavioral)
ARM 3 - Rotatory Chair + Telerehabilitation
Participants receive the same vestibular telerehabilitation program as Arm 2 (three weeks before surgery and three weeks after surgery), plus six supervised preoperative sessions of controlled rotatory chair stimulation performed in the ENT department.
干预措施: Structured home-based vestibular telerehabilitation program (Behavioral)
ARM 3 - Rotatory Chair + Telerehabilitation
Participants receive the same vestibular telerehabilitation program as Arm 2 (three weeks before surgery and three weeks after surgery), plus six supervised preoperative sessions of controlled rotatory chair stimulation performed in the ENT department.
干预措施: CE-marked clinical rotatory chair (Device)
结局指标
主要结局
Video Hit Impulse Test (VHIT)
时间窗: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
posturography
时间窗: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Dizzines Handicap Inventory
时间窗: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
a 25-item self-reported questionnaire assessing perceived handicap due to dizziness, with total scores ranging from 0 to 100. Higher scores indicate greater perceived disability.
Lenght of hospital stay (LOS)
时间窗: From surgery to hospital discharge (assessed at discharge)
次要结局
- Post-rotatory nystagmus inhibition time (TINPR)(During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery))
- Age(At enrollment)
- Sex(At enrollment)
- Tumor size(At enrollment)
研究者
Albert Torrents Torrero
Sub-Investigator Phd Student
Universitat Autonoma de Barcelona