100 Participants Needed

Vestibular Therapy for Alzheimer's Disease

YA
Overseen ByYuri Agrawal, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12346

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.12346

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.

Research Team

YA

Yuri Agrawal, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.
See 3 more

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Vestibular therapyExperimental Treatment1 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 controlActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. [2020]
Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. [2022]
Physical and Vestibular Physical Therapy Referrals in People With Alzheimer Disease. [2023]
Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. [2022]
Sensor-based balance training with motion feedback in people with mild cognitive impairment. [2020]
Vestibular Physical Therapy and Fall Risk Assessment. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security