Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma
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
2 other identifiers
interventional
75
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 23, 2026
January 1, 2026
1.6 years
December 24, 2025
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Video Hit Impulse Test (VHIT)
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
posturography
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
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.
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery
Lenght of hospital stay (LOS)
From surgery to hospital discharge (assessed at discharge)
Secondary Outcomes (4)
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
Study Arms (3)
ARM 1 - No Intervention Group
OTHERParticipants 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.
ARM 2 - Group Telerehabilitation Only
ACTIVE 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.
ARM 3 - Rotatory Chair + Telerehabilitation
EXPERIMENTALParticipants 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.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- Age between 18 and 70 years
- Tumor size between 1.5 cm and 4 cm
- Unilateral vestibular schwannoma
You may not qualify if:
- Degenerative neurological conditions
- History of cerebrovascular disease
- Musculoskeletal deformities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Germans Trias i Pujol Hospitalcollaborator
- Universitat Autonoma de Barcelonacollaborator
- Albert Torrents Torrerolead
Study Sites (1)
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Related Publications (4)
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.
PMID: 34864777BACKGROUNDEnticott 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: 15793417BACKGROUNDBatuecas-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: 24114593BACKGROUNDGonzalez-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: 40102225BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Sequential convenience sampling approach.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sub-Investigator Phd Student
Study Record Dates
First Submitted
December 24, 2025
First Posted
January 23, 2026
Study Start
September 1, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Beginning 6 months after publication of the primary study results and remaining available for 5 years thereafter.
- 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.
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.