Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma

January 18, 2026 updated by: Albert Torrents Torrero

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Àngela Callejo Castillo, MD, PhD
        • Principal Investigator:
          • Maria José Durà Mata, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Active Comparator: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Video Hit Impulse Test (VHIT)
Time Frame: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
posturography
Time Frame: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Dizzines Handicap Inventory
Time Frame: 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.
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Lenght of hospital stay (LOS)
Time Frame: From surgery to hospital discharge (assessed at discharge)
From surgery to hospital discharge (assessed at discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-rotatory nystagmus inhibition time (TINPR)
Time Frame: During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery)
only for group 3
During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery)
Age
Time Frame: At enrollment
At enrollment
Sex
Time Frame: At enrollment
At enrollment
Tumor size
Time Frame: At enrollment
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Torrents Torrero

Collaborators

Germans Trias i Pujol Hospital
Universitat Autonoma de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRV-SCHW25
  • PI-25-112 (Other Identifier: Research Ethics Committee oh Hospital Universitari Germans Trias i Pujol)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to share de-identified individual participant data underlying the results reported in publications arising from this study, including data related to primary and secondary outcomes such as vestibular function measures (e.g., vHIT parameters), posturography results, Dizziness Handicap Inventory (DHI) scores, and hospital length of stay. No directly identifiable personal data will be shared. Data will be available from 6 months after publication of the primary results and for up to 5 years thereafter, and will be shared with qualified researchers upon reasonable request and submission of a scientifically sound proposal related to vestibular rehabilitation or postoperative recovery. Approved data will be provided through secure institutional file transfer systems or controlled-access repositories, in accordance with applicable ethical approvals, informed consent, and data protection regulations.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary study results and remaining available for 5 years thereafter.

IPD Sharing Access Criteria

Access to de-identified individual participant data and supporting documentation will be granted to qualified researchers who submit a reasonable, methodologically sound research proposal related to vestibular rehabilitation, vestibular compensation, or postoperative recovery. Requests will be reviewed by the study investigators to ensure scientific merit, ethical compatibility, and alignment with the scope of the original study. Approved applicants will be required to agree to conditions of data use, including appropriate data protection measures and acknowledgment of the original study. Data will be shared through secure institutional file transfer systems or controlled-access repositories following approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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