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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05702749
Status
Recruiting
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Conditions

  • Vestibular Schwannoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microsurgical resection of VS — PROCEDURE
    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.
  • Stereotactic radiosurgery — RADIATION
    Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
  • PREHAB — OTHER
    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).

Study Details

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.

Key Dates

Start date
Jan 22, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Sensory Organization Test Score at Post-Treatment Assessments [ Time Frame: Post-treatment 1 week ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226
Michael Harris, MD
[email protected]

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By research site
Froedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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