Vestibular Rehabilitation for Vestibular Disorders

(APV Trial)

Overseen By Chelsea Behling

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Cognition, Visual acuity, Sensation, Mobility

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is vestibular rehabilitation therapy generally safe for humans?

Vestibular rehabilitation therapy is generally considered safe, with few reported adverse effects. However, like any therapy, it may have some risks, and large-scale studies are needed to better understand the potential for serious adverse reactions. ^{1 2 3 4 5}

How is vestibular rehabilitation treatment different from other treatments for vestibular disorders?

Vestibular Rehabilitation Therapy (VRT) is unique because it uses specific exercises to improve balance and reduce dizziness by retraining the brain to process signals from the inner ear and eyes more effectively. Unlike medications that may only mask symptoms, VRT addresses the root cause of balance issues and dizziness by enhancing the body's natural ability to adapt and compensate for vestibular dysfunction. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Vestibular Rehabilitation for Vestibular Disorders?

Research shows that vestibular rehabilitation therapy (VRT) is an effective treatment for patients with dizziness and balance issues, especially in the elderly with chronic vestibular dysfunction. It helps improve symptoms like vertigo (a spinning sensation), gaze instability, and balance problems. ^{6 11 12 13 14}

Who Is on the Research Team?

Brooke Klatt, PhD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

This trial is for adults over 18 with dizziness or imbalance due to a diagnosed unilateral vestibular disorder. Participants must be able to move around in the community, have decent vision (20/40 or better with glasses), and good sensation in their feet.

Exclusion Criteria

Visual acuity worse than 20/40 with corrected lenses

Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)

I cannot move around in community settings on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard vestibular rehabilitation

8 weeks

Follow-up

Participants are monitored for changes in activity and participation after rehabilitation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vestibular Rehabilitation

Trial Overview The study is testing how well vestibular rehabilitation helps people with balance disorders improve their daily activities and participation. It involves assessing patients before and after they complete the rehab program.

How Is the Trial Designed?

Group I: Standard Vestibular Rehabilitation Experimental Treatment 1 Intervention

All participants will receive standard vestibular rehabilitation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The study established the minimal clinically important difference (MCID) for the Activities-specific Balance Confidence Scale (ABC), Functional Gait Assessment (FGA), and Gait Speed (GS) in individuals with vestibular disorders, with values of 18.1%, 4 points, and 0.09 m/s respectively, based on a sample of 222 to 237 subjects.

These MCID values, derived using an anchor-based approach with the Dizziness Handicap Inventory (DHI) as a reference, provide important benchmarks for assessing meaningful improvements in gait and balance following vestibular rehabilitation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. Wellons, RD., Duhe, SE., MacDowell, SG., et al.[2022]

Vestibular rehabilitation therapy (VRT) significantly improved dizziness in elderly patients with chronic vestibular dysfunction, as shown by a notable decrease in dizziness handicap inventory (DHI) scores after 8 weeks of therapy.

In a study of 33 patients over 60 years old, VRT exercises led to marked improvements in balance and function, particularly in those with abnormal canal paralysis, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Bayat, A., Pourbakht, A., Saki, N., et al.[2022]

Customized vestibular rehabilitation therapy (VRT) is an effective treatment for patients experiencing symptoms like vertigo, gaze instability, and balance issues due to vestibular dysfunction.

The paper outlines specific patient selection criteria and rehabilitation strategies for both unilateral and bilateral vestibular deficits, highlighting the strong evidence supporting VRT's efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the dizzy patient. Tee, LH., Chee, NW.[2022]

In a study involving 47 participants with peripheral vestibular disorders, both those with only semicircular canal dysfunction and those with additional otolith dysfunction showed significant improvements after an 8-week vestibular rehabilitation program.

The presence of otolith dysfunction did not significantly affect the outcomes of rehabilitation, indicating that vestibular rehabilitation is effective for improving symptoms and balance regardless of otolith involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does otolith organ dysfunction influence outcomes after a customized program of vestibular rehabilitation? Murray, KJ., Hill, K., Phillips, B., et al.[2022]

In a study of 74 participants with chronic dizziness, those who received expert physiotherapist guidance in a home-based vestibular rehabilitation therapy (VRT) program showed significantly greater improvement in their dizziness scores compared to those who exercised without specific instructions.

Both groups improved over the 8-week study, but the intervention group experienced a more substantial reduction in their Dizziness Handicap Inventory scores, highlighting the importance of tailored instructions for maximizing the effectiveness of home exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). Kellerer, S., Amberger, T., Schlick, C., et al.[2023]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

From 1999 to 2003, a pharmacovigilance system at Toulouse University Hospital collected data on antiretroviral drug-induced adverse reactions (ADRs), reporting a total of 613 ADRs from 428 patients.

The majority of reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required withdrawal of the suspected drugs, highlighting the importance of monitoring and reporting ADRs for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of antiretroviral drugs-induced adverse effects]. Baudrant, M., Bagheri, H., Cuzin, L., et al.[2018]

Between 1999 and 2003, a study at Toulouse University Hospital reported 613 adverse drug reactions (ADRs) from antiretroviral drugs affecting 428 patients, highlighting the importance of monitoring these effects.

Most reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required stopping the suspected medication, indicating that while many reactions were mild, a significant portion still necessitated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Bandrant, M., Bagheri, H., Cuzin, L., et al.[2016]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an Adverse Experience Reporting Program (AERP Vet) that investigates reports of adverse effects from veterinary medicines, ensuring the safety and efficacy of these products.

This program helps veterinarians trust the quality of the veterinary drugs they use, enhancing their confidence in administering these medications to animals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The veterinary pharmacovigilance program of the APVMA. Linnett, P., Dagg, P.[2019]

In a survey of 127 Chartered Physiotherapists, 26% reported experiencing adverse effects from manipulation techniques, with a higher incidence linked to non-High Velocity Thrust Techniques (20%) compared to High Velocity Thrust Techniques (4%).

Serious adverse effects, including a Transient Ischemic Attack (TIA), were associated with non-HVTT, highlighting the need for improved risk assessment and reporting systems for adverse reactions in physiotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy for the cervical spine and reported adverse effects: a survey of Irish manipulative physiotherapists. Sweeney, A., Doody, C.[2015]

Vestibular Rehabilitation Therapy (VRT) is an effective treatment for many patients with vestibular disorders and balance dysfunctions, helping to improve their symptoms.

The paper outlines various assessment methods and treatment strategies for VRT, emphasizing its importance in managing balance-related issues in patients seeking help from otolaryngologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. Girardi, M., Konrad, HR.[2005]

Vestibular rehabilitation significantly improved the diagnosis of vestibular peripheral disorders, with 75% of participants showing a transition to normal vestibular patterns.

The Brazilian Dizziness Handicap Inventory (DHI) proved to be an effective tool for assessing changes in quality of life and diagnosing vestibular disorders in individuals undergoing rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study about the benefits of vestibular rehabilitation in peripheral vestibular disorders]. Segarra-Maegaki, JA., Taguchi, CK.[2015]

Vestibular rehabilitation is an effective intervention for individuals with balance and vestibular disorders, aimed at improving functional abilities and reducing dizziness symptoms.

The program includes specific exercises and outcome measures to track progress, while also identifying factors that can positively or negatively influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of vestibular physical therapy rehabilitation. Whitney, SL., Sparto, PJ.[2023]

A pilot study involving 10 individuals with vestibular disorders showed that four weeks of telerehabilitation combining gaze stability and balance exercises significantly improved balance and reduced dizziness-related handicap, as measured by the Berg Balance Scale and Dizziness Handicap Inventory.

While the intervention was effective in enhancing balance and daily living activities, it did not lead to significant improvements in the Activities-Specific Balance Confidence scale, indicating that while physical balance improved, confidence in balance may require additional focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combined effect of gaze stability and balance exercises using telerehabilitation in individuals with vestibular disorders during the COVID-19 pandemic: A pilot study. Aldawsary, N., Almarwani, M.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. [2022]

2. Estonia pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the dizzy patient. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Does otolith organ dysfunction influence outcomes after a customized program of vestibular rehabilitation? [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Analysis of antiretroviral drugs-induced adverse effects]. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Not Available]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

The veterinary pharmacovigilance program of the APVMA. [2019]

10. Scotland pubmed.ncbi.nlm.nih.gov

Manual therapy for the cervical spine and reported adverse effects: a survey of Irish manipulative physiotherapists. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. [2005]

12. Brazil pubmed.ncbi.nlm.nih.gov

[Study about the benefits of vestibular rehabilitation in peripheral vestibular disorders]. [2015]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Principles of vestibular physical therapy rehabilitation. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

The combined effect of gaze stability and balance exercises using telerehabilitation in individuals with vestibular disorders during the COVID-19 pandemic: A pilot study. [2023]