Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlbert Torrents Torrero
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years
Tumor size between 1.5 cm and 4 cm
Unilateral vestibular schwannoma
Disqualifiers
Degenerative neurological conditions
History of cerebrovascular disease
Musculoskeletal deformities
Trial design
Design model
Parallel
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionParticipants 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 program
BehavioralStructured 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 chair
DeviceSix 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: ARM 1 - No Intervention GroupOther 1 intervention
Group B: ARM 2 - Group Telerehabilitation OnlyActive comparator 1 intervention
Group C: ARM 3 - Rotatory Chair + TelerehabilitationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Video Hit Impulse Test (VHIT)
Time frame
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery2
posturography
Time frame
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery3
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.
Time frame
Baseline (4 weeks before surgery), and at 3 and 12 weeks after surgery4
Lenght of hospital stay (LOS)
Time frame
From surgery to hospital discharge (assessed at discharge)Secondary outcomes
1
Post-rotatory nystagmus inhibition time (TINPR)
only for group 3
Time frame
During each preoperative rotatory chair stimulation session (over the 3 weeks before surgery)2
Age
Time frame
At enrollment3
Sex
Time frame
At enrollment4
Tumor size
Time frame
At enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert Torrents Torrero
Lead sponsor
Universitat Autonoma de Barcelona
Sponsor institution
Germans Trias i Pujol Hospital
Collaborator
Universitat Autonoma de Barcelona
Collaborator
Source ClinicalTrials.gov