Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma

Официальное название

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

Обзор

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.

Подробное описание

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.

Telerehabilitation is delivered through the ReHub platform, which provides guided vestibular exercises, real-time feedback, adherence tracking, and clinician monitoring. Preoperative rotatory stimulation consists of six supervised sessions over three weeks (two per week), following a structured progression in rotational velocity and post-rotation visual fixation tasks. The purpose of this stimulation is to facilitate preoperative habituation, improve gaze stabilization mechanisms, and prime central vestibular adaptation prior to the abrupt loss of vestibular function caused by surgery.

All participants undergo standardized assessments of vestibular function and balance control at predefined time points. These include the video Head Impulse Test (vHIT) to quantify VOR gain and refixation saccades, dynamic posturography to evaluate postural stability, and the Dizziness Handicap Inventory (DHI) to assess perceived disability. Hospital length of stay (LOS) is obtained directly from clinical records. Assessments are performed four weeks before surgery and at 4 and 12 weeks postoperatively.

The three-group design allows evaluation of:

1. the effect of pre- and postoperative vestibular telerehabilitation compared with no intervention, 2. the added effect of preoperative rotatory chair stimulation beyond telerehabilitation alone, and 3. the overall magnitude of combined preoperative rehabilitation strategies on functional recovery.

The study uses a sequential convenience sampling approach due to practical and ethical considerations related to implementation of the interventions. All data are collected at a tertiary referral center with specialized vestibular and neurotologic resources, ensuring standardized assessments and consistent clinical follow-up.

The primary objective is to compare postoperative vestibular compensation across groups, evaluated through changes in vHIT gain and refixation saccade patterns. Secondary objectives include differences in posturography metrics, DHI scores, and length of hospital stay. Additional exploratory analyses will examine the influence of age, sex, tumor size, and preoperative post-rotatory nystagmus inhibition time (TINPR) on rehabilitation outcomes.

The trial aims to generate evidence to inform future standardized rehabilitation pathways for patients undergoing vestibular schwannoma surgery, integrating digital rehabilitation tools and targeted vestibular stimulation to optimize central compensation mechanisms.

Вмешательства

• Другое No Intervention: Observational Cohort
  Participants undergo the standard surgical treatment for unilateral vestibular schwannoma and complete protocol assessments (vHIT, posturography, DHI, and hospital length of stay). They do not receive any preoperative or postoperative vestibular rehabilitation.
• Поведенческое Structured home-based vestibular telerehabilitation program
  Structured home-based vestibular rehabilitation program delivered through the ReHub digital platform for 3 weeks before surgery and 3 weeks after surgery, including gaze stabilization, balance, and habituation exercises with remote supervision.
• Устройство CE-marked clinical rotatory chair
  Six supervised sessions of controlled vestibular stimulation delivered over 3 weeks using a CE-marked clinical rotatory chair following a progressive protocol in rotational velocity and post-rotation fixation tasks.

Первичные конечные точки

• Video Hit Impulse Test (VHIT) [Срок оценки: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery]
• posturography [Срок оценки: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery]
• Dizzines Handicap Inventory [Срок оценки: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery]
• Lenght of hospital stay (LOS) [Срок оценки: From surgery to hospital discharge (assessed at discharge)]

Вторичные конечные точки (4)

• Post-rotatory nystagmus inhibition time (TINPR) [Срок оценки: During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery)]
• Age [Срок оценки: At enrollment]
• Sex [Срок оценки: At enrollment]
• Tumor size [Срок оценки: At enrollment]

Критерии участия

Критерии включения

• Age between 18 and 70 years
• Tumor size between 1.5 cm and 4 cm
• Unilateral vestibular schwannoma

Критерии исключения

• Degenerative neurological conditions
• History of cerebrovascular disease
• Musculoskeletal deformities

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitari Germans Trias i Pujol — Badalona

Публикации

• Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy As PMID 34864777
• Enticott JC, O'leary SJ, Briggs RJ. Effects of vestibulo-ocular reflex exercises on vestibular compensation after vestibular schwannoma surgery. Otol Neurotol. 2005 Mar;26(2):265-9. doi: 10.1097/00129492-200503000-00024. PMID 15793417
• Batuecas-Caletrio A, Santacruz-Ruiz S, Munoz-Herrera A, Perez-Fernandez N. The vestibulo-ocular reflex and subjective balance after vestibular schwannoma surgery. Laryngoscope. 2014 Jun;124(6):1431-5. doi: 10.1002/lary.24447. Epub 2013 Nov 13. PMID 24114593
• Gonzalez-Garcia M, Prieto-Sanchez-de-Puerta L, Montilla-Ibanez MA, Dominguez-Duran E, Sanchez-Gomez S, Sedeno-Vidal A. Efficacy of vestibular rehabilitation using unidirectional rotation paradigm in VOR asymmetry: systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2025 Aug;282(8):3845-3853. doi: 10.1007/s00405-025-09282-3. Epub 2025 Mar 18. PMID 40102225

Идентификаторы

NCT: NCT07364955 · PRV-SCHW25 · PI-25-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗