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Vestibular SchwannomaNCT07364955

Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma

A study testing Structured home-based vestibular telerehabilitation program and CE-marked clinical rotatory chair in people with Vestibular Schwannoma and Vestibular Schwannomas, run by Albert Torrents Torrero at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Vestibular Schwannoma, Vestibular Schwannomas
What is being tested?
Structured home-based vestibular telerehabilitation program and CE-marked clinical rotatory chair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
1 Sep 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Albert Torrents Torrero, PT, MsC contact

+34687975352

albert.torrents1@gmail.com

Spain1 site, 1 recruiting
  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Albert Torrents Torrero, PT, MSc, +34687975352, albert.torrents1@gmail.com

    Àngela Callejo Castillo, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
No Intervention: Observational Cohort, Structured home-based vestibular telerehabilitation program, CE-marked clinical rotatory chair
Keywords
Vestibular rehabilitation, Vestibular prehabilitation, Vestibular prehab
Medical subject headings
Neuroma, Acoustic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    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.

  • Structured home-based vestibular telerehabilitation programBehavioural

    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.

  • CE-marked clinical rotatory chairDevice

    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.

Study groups in NCT07364955
Study groupRoleWhat they receive
ARM 1 - No Intervention GroupOtherParticipants 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.
Receives: Other: No Intervention: Observational Cohort
ARM 2 - Group Telerehabilitation OnlyActive comparatorParticipants 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.
Receives: Behavioral: Structured home-based vestibular telerehabilitation program
ARM 3 - Rotatory Chair + TelerehabilitationExperimentalParticipants 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.
Receives: Behavioral: Structured home-based vestibular telerehabilitation program; Device: CE-marked clinical rotatory chair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Video Hit Impulse Test (VHIT)

    Measured: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery

  2. posturography

    Measured: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery

  3. Dizzines Handicap Inventory

    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.

    Measured: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery

  4. Lenght of hospital stay (LOS)

    Measured: From surgery to hospital discharge (assessed at discharge)

Secondary outcomes (4)
  1. Post-rotatory nystagmus inhibition time (TINPR)

    only for group 3

    Measured: During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery)

  2. Age

    Measured: At enrollment

  3. Sex

    Measured: At enrollment

  4. Tumor size

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start1 Sep 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Group 1) No-intervention group Group 2) Telerehabilitation program (ReHub) for 3 weeks before surgery and again for 3 weeks after surgery. Group 3) Rotatory Chair + Telerehabilitation program
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364955
Sponsor's protocol ID
PRV-SCHW25
Other IDs
PI-25-112
Status last verified
Jan 2026
First submitted
24 Dec 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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 Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40102225

Questions about this trial

What is this clinical trial studying?

A study testing Structured home-based vestibular telerehabilitation program and CE-marked clinical rotatory chair in people with Vestibular Schwannoma and Vestibular Schwannomas, run by Albert Torrents Torrero at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Albert Torrents Torrero, PT, MsC (+34687975352, albert.torrents1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Video Hit Impulse Test (VHIT) (time frame: Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364955, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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