Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05702749

Evaluating Pre-Treatment Vestibular Physical Therapy Rehabilitation for Patients with Vestibular Schwannomas Undergoing Surgery or Radiosurgery

Led by Medical College of Wisconsin · Updated on 2026-03-24

36

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of pre-treatment vestibular physical therapy rehabilitation (PREHAB) in patients with Vestibular Schwannomas (VS) who are undergoing either surgery or stereotactic radiosurgery (SRS). This pilot randomized study aims to estimate balance scores before and after treatment to better understand how PREHAB may influence recovery. The study enrolls patients diagnosed with VS who are eligible for either surgical or radiosurgical management. Participants will be randomized into four groups: PREHAB plus surgery, surgery alone, PREHAB plus radiosurgery, and radiosurgery alone. PREHAB involves weekly visits for three weeks before treatment to develop an exercise program including balance exercises twice daily, gaze stabilization exercises for 12 to 20 minutes daily, and habituation exercises as applicable. Surgical approaches include microsurgical resection using various techniques, while radiosurgery is delivered as a single fraction using Gamma Knife or linear accelerator technology. During the study, participants will undergo baseline and multiple post-treatment balance assessments using the Sensory Organization Test at 1 week, 6 weeks, 6 months, and 12 months after treatment. Researchers will monitor participants' adherence to therapy exercises and collect self-reported questionnaires. The total involvement includes initial PREHAB visits (if assigned), treatment procedures, and follow-up balance evaluations over a year to assess outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Male or female participants 18 years of age or older
  • Initial diagnosis of Vestibular Schwannoma confirmed by MRI
  • Tumor size 2.5 cm or smaller
  • Planned treatment with surgery or stereotactic radiosurgery
  • ECOG Performance Status less than 2
  • Normal laboratory values within 14 days prior to registration, supporting safe treatment
  • Willingness to follow study protocol and complete questionnaires
  • For females of reproductive potential: negative pregnancy test within 7 days prior to enrollment and agreement to use effective contraception during study and for 24 weeks after radiosurgery
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Prior treatment for Vestibular Schwannoma including surgery, radiotherapy, or salvage procedures
  • Secondary vestibular diagnoses such as Meniere's disease, intractable benign paroxysmal positional vertigo, vestibular migraine, or 3PD
  • Medical conditions significantly affecting balance or vestibular testing, including prior stroke or uncorrected vision impairment
  • Planned radiation treatment other than stereotactic radiosurgery
  • Inability to safely undergo MRI scans
  • Allergy to gadolinium contrast used in MRI
  • Pregnant women or females unwilling to use contraception during study and 24 weeks post radiosurgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Run-in Period

Duration - 3 weeks

Participants in the PREHAB groups attend weekly physical therapy visits to determine a personalized exercise regimen including balance, gaze stabilization, and habituation exercises to be done daily before surgery or radiosurgery.

3 weekly visits (in-person)

Treatment

Duration - Single day for surgery or radiosurgery

Participants undergo either microsurgical resection of vestibular schwannoma or stereotactic radiosurgery as determined by clinical consultation and randomization.

1 treatment visit (in-person)

Post-treatment Follow-up

Duration - 12 months

Participants are assessed to monitor recovery and sensory organization at multiple time points after treatment.

4 follow-up visits at 1 week, 6 weeks, 6 months, and 12 months post-treatment

Trial Site Locations

Total: 1 location

1

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Medical College of Wisconsin Cancer Center Clinical Trials Office

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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Published Research Related To This Trial

The relationship between falls history and computerized dynamic posturography in persons with balance and vestibular disorders.

Susan L Whitney, Gregory F Marchetti, Annika I Schade

https://pubmed.ncbi.nlm.nih.gov/16500176

Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association.

Courtney D Hall, Susan J Herdman, Susan L Whitney...

https://pubmed.ncbi.nlm.nih.gov/34864777