Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients with Vestibular Schwannomas (VS PREHAB)

In-Person Study

Purpose

The investigators aim to estimate mean baseline and post-treatment balance scores among Vestibular Schwannomas (VS) patients undergoing pretreatment rehab (PREHAB) or no PREHAB when managed with either surgery or radiosurgery.

Study Overview

A PREHAB visit will be done once weekly for three weeks to determine exercise regimen prior to surgery or radiotherapy. Therapy includes balance exercises (twice daily), gaze stabilization exercises (12-20 minutes daily), and habituation exercises (as applicable). Standard surgical approaches including retrosigmoid, translabyrinthine, and middle fossa and radiosurgical (SRS) delivery will be determined based on current VS management guidelines and followed by study randomization to PREHAB.

Eligibility Criteria

1. Provision of signed and dated informed consent form
2. Male or female participants ≥18 years of age.
3. Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice
4. VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS
5. Eastern Cooperative Oncology Group (ECOG) Performance Status <2
6. Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator
7. Be willing to adhere to outlined study protocol criteria and complete self-reported questionnaires (translations may be made available if the patient' primary language is not English).
8. For females of reproductive potential: must have a negative urine or serum pregnancy test 7 prior to enrollment and agreement to use of highly effective contraception method during study participation and for an additional 24 weeks after the completion of stereotactic radiosurgery.

Location:
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, WI, USA

Contact:
Michael Harris, MD
Medical College of Wisconsin
Email: msharris@mcw.edu

For more information:
https://clinicaltrials.gov/study/NCT05702749?term=vestibular%20prehab&rank=1#study-overview