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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Male or female participants ≥18 years of age.

• Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice

• VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS

• Eastern Cooperative Oncology Group (ECOG) Performance Status \<2

• Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator

• 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).

• 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.

Locations
United States
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Medical College of Wisconsin Cancer Center Clinical Trials Office
cccto@mcw.edu
866-680-0505
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 36
Treatments
Active_comparator: Intervention: PREHAB and Surgery
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.
Placebo_comparator: Control: Surgery (No PREHAB)
Subjects will undergo microsurgical resection of VS.
Active_comparator: Intervention: PREHAB and SRS
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.
Placebo_comparator: Control: SRS (No PREHAB)
Subjects will undergo stereotactic radiosurgery.
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov

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