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 trial aims to examine how balance problems and individual factors affect daily activities in people with vestibulopathy, a condition that causes dizziness and imbalance. Participants will undergo vestibular rehabilitation, a series of exercises designed to improve balance and reduce dizziness. The study will collect data before and after the treatment to assess its impact. Individuals who often feel dizzy or unsteady and have been diagnosed with unilateral vestibular hypofunction might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for vestibulopathy.

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.

What prior data suggests that vestibular rehabilitation is safe for vestibular disorders?

Research has shown that vestibular rehabilitation is generally safe for people with balance and dizziness issues. This exercise-based treatment improves symptoms like dizziness and imbalance without causing serious side effects. One study found that patients with balance problems successfully used virtual reality for rehabilitation, proving it both safe and effective. Another study demonstrated that vestibular therapy could be conducted in an emergency room, helping reduce dizziness over time. Overall, the treatment is well-tolerated and aids in regaining balance, making it a reliable option for those with vestibular disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vestibular rehabilitation for vestibular disorders because it offers a targeted approach to improving balance and reducing dizziness. Unlike medications that primarily manage symptoms, this rehabilitation method focuses on retraining the brain to compensate for inner ear issues through specialized exercises. This therapy can be customized to each patient's specific needs, potentially leading to more effective and lasting relief compared to standard drug treatments.

What evidence suggests that vestibular rehabilitation is effective for vestibular disorders?

Research has shown that vestibular rehabilitation can help people with balance problems feel better. One study found that after about 4 to 6 weeks of this therapy, patients felt less dizzy and could do more daily activities. Another study demonstrated that those who received therapy felt less dizzy and were more willing to engage in activities they previously avoided. Overall, current evidence suggests that vestibular rehabilitation can decrease dizziness and improve quality of life. ^{3 4 5 6 7}

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

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390126/

Effectiveness of virtual reality-based vestibular rehabilitation in ... In our study, we showed that the symptoms of PVH patients were reduced, and their quality of life improved after VR-based VRT treatment. It was also observed ...

2. e-rvs.org e-rvs.org/journal/view.php?number=985

Clinical application of virtual reality for vestibular ... This enhanced focus and engagement hold promise for more successful outcomes in VRT, improving the effectiveness of the rehabilitation process.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1329418/full

Efficacy of vestibular rehabilitation and its facilitating and ... Results: After the median of 6 (4–6) weeks of rehabilitation, DHI and VADL scores significantly improved in patients with either peripheral or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1808869421001725

Effectiveness of conventional versus virtual reality-based ... Our results revealed that the virtual reality-based vestibular rehabilitation exercises may be an effective treatment in reducing dizziness, disability due to ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830236

Emergency Department Vestibular Rehabilitation Therapy ... Patients receiving ED vestibular therapy reported greater improvements in dizziness handicap, vestibular activities avoidance, and sedating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3259492/

Vestibular Rehabilitation Therapy: Review of Indications ... Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7871733/

Virtual Reality Vestibular Rehabilitation in 20 Patients with ... Vestibular rehabilitation is a safe and effective method for vestibular rehabilitation and in treating unilateral vestibular hypofunction [17,18]. Exercises ...