NCT05702749

Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a pilot efficacy study. 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.

Detailed description

Study Design: This is a pilot randomized study with enrollment of 9 patients each to 4 groups: PREHAB+Surgery, No PREHAB+Surgery, PREHAB+Radiosurgery, and No PREHAB+Radiosurgery. Eighteen patients will be enrolled to receive each treatment type: surgery and radiosurgery. Within each type, patients will be randomized to PREHAB or NO PREHAB at a 1:1 ratio using stratified permuted blocks. The treatment modality will be determined by the patient and investigator(s) based upon collective consultations with neuro-otology, neurosurgery, and radiation oncology aligned with the Medical College of Wisconsin sporadic VS treatment guidelines. Study Intervention: 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.

Conditions

• Vestibular Schwannoma

Interventions

Type	Name	Description
PROCEDURE	Microsurgical resection of VS	Microsurgical resection of VSs can be accomplished by three approaches including middle cranial fossa, retrosigmoid, and translabyrinthine. The surgical approach utilized is typically selected on the basis of tumor location and size, and patient age and hearing status.
RADIATION	Stereotactic radiosurgery	Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
OTHER	PREHAB	A PREHAB visit will be done once weekly for 3 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).

Timeline

• Start date: 2024-01-22
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2023-01-27
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study