Vestibular Therapy for Alzheimer's Disease

Overseen By Yuri Agrawal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Antihistamines, Benzodiazepines

Disqualifiers: Severe AD, Non-AD dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.

Will I have to stop taking my current medications?

If you are taking daily vestibular suppressant medications like anti-histamines or benzodiazepines, you will need to stop them to participate in the trial.

Is vestibular therapy safe for people with Alzheimer's disease?

Vestibular therapy is generally considered safe and is used to improve balance and reduce fall risk in people with vestibular disorders, including those with Alzheimer's disease. ^{1 2 3 4 5}

How is vestibular therapy different from other treatments for Alzheimer's disease?

Vestibular therapy is unique for Alzheimer's patients because it focuses on improving balance and reducing fall risk by addressing vestibular (inner ear balance) impairments, which are common in these patients but often overlooked. Unlike other treatments that may not target balance issues directly, this therapy uses specialized exercises to enhance vestibular function and motor learning, potentially reducing falls and improving quality of life. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Vestibular Therapy for Alzheimer's Disease?

Research suggests that vestibular therapy can improve balance and reduce the risk of falls in people with Alzheimer's disease, as it is effective in addressing vestibular impairments, which are common in these patients. Although not specifically tested in Alzheimer's patients, similar therapies have shown benefits in improving balance in individuals with cognitive impairments. ^{1 2 4 5 6}

Who Is on the Research Team?

Yuri Agrawal, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people over 60 with mild-to-moderate Alzheimer's who have balance issues due to inner ear problems. They need a caregiver available and must be able to do certain tests and therapy sessions. Those with severe Alzheimer's, other dementias, or conditions that limit participation (like needing a cane) can't join.

Inclusion Criteria

You have problems with balance and dizziness due to issues with your inner ear.

I have been diagnosed with mild to moderate Alzheimer's disease.

I have a caregiver who can spend at least 10 hours a week with me and participate in study procedures.

Exclusion Criteria

I am not taking daily medications for dizziness, like anti-histamines or benzodiazepines.

I cannot commit to 8 weeks of the treatment or control program.

I am unable to take part in the study due to health issues or need for mobility aids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week course of vestibular therapy or active control exercises

8 weeks

Follow-up

Participants are monitored for incidence of falls over a 1-year period

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Active control
• Vestibular physical therapy

Trial Overview The study is testing if vestibular therapy, which helps improve balance by focusing on the inner ear system, can reduce falls in Alzheimer's patients. Participants will either receive this special therapy or an active control treatment in a randomized setup.

How Is the Trial Designed?

Group I: Vestibular therapy Experimental Treatment 1 Intervention

Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.

Group II: Active control Active Control 1 Intervention

The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Individuals with Alzheimer's disease (AD) have a higher prevalence of vestibular impairment, which increases their risk of falls, making it a significant health concern for them and their caregivers.

The article proposes a modified vestibular physical therapy (VPT) protocol tailored for individuals with cognitive impairment, focusing on their motor learning abilities and the importance of building a strong therapeutic relationship, with ongoing research assessing its effectiveness in improving balance and reducing falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. Klatt, BN., Ries, JD., Dunlap, PM., et al.[2020]

This pilot clinical trial aims to evaluate the feasibility of vestibular therapy (VT) in reducing falls and improving balance in 100 patients with mild to moderate Alzheimer's disease who have vestibular loss, with assessments conducted at baseline, 8 weeks, and 1 year.

Falls are a major concern for Alzheimer's patients, and this study seeks to address the high risk of falls by implementing VT, which has been shown to improve balance and reduce fall risk, potentially benefiting a growing population of AD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Yesantharao, LV., Rosenberg, P., Oh, E., et al.[2022]

In a study of 801 patients with Alzheimer disease, only 6.0% were referred to physical therapy (PT) and a mere 0.6% to vestibular physical therapy (VPT), indicating a significant underutilization of these beneficial interventions.

Despite the known benefits of PT and VPT in improving balance and reducing fall risk in individuals with Alzheimer disease, the low referral rates suggest a gap in care that could impact patient safety and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Vestibular Physical Therapy Referrals in People With Alzheimer Disease. Gandhi, P., Klatt, BN., Agrawal, Y.[2023]

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]

A pilot study involving 22 participants with mild cognitive impairment showed that a novel sensor-based balance training program significantly reduced postural sway and fear of falling after 4 weeks of training, indicating its potential efficacy in improving balance.

The majority of participants (92%) found the training enjoyable and felt that the real-time feedback from wearable sensors was helpful, suggesting a positive user experience that supports the feasibility of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-based balance training with motion feedback in people with mild cognitive impairment. Schwenk, M., Sabbagh, M., Lin, I., et al.[2020]

Vestibular physical therapy (VPT) is an evidence-based treatment aimed at reducing symptoms like vertigo, dizziness, and imbalance, which can significantly improve patients' quality of life.

The therapy emphasizes patient safety and includes fall risk assessments to prevent falls, making it a comprehensive approach to managing vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy and Fall Risk Assessment. Carender, WJ., Grzesiak, M., Telian, SA.[2021]

Citations

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

Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. [2022]

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

Physical and Vestibular Physical Therapy Referrals in People With Alzheimer Disease. [2023]

4. Estonia pubmed.ncbi.nlm.nih.gov

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

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

Sensor-based balance training with motion feedback in people with mild cognitive impairment. [2020]

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

Vestibular Physical Therapy and Fall Risk Assessment. [2021]