Vestibular Therapy in Alzheimer's Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: No
View:

• Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).

• Age ≥ 60 years.

• Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).

• Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.

• Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.

• Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Locations
United States
Maryland
Johns Hopkins University School of Medicine
Recruiting
Baltimore
Contact Information
Primary
Yuri Agrawal, MD
yagrawa1@jhmi.edu
4105023107
Time Frame
Start Date: March 1, 2021
Estimated Completion Date: June 30, 2024
Participants
Target number of participants: 100
Treatments
Experimental: Vestibular therapy
Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.
Active Comparator: Active control
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.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov

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