Vestibular Therapy in Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJohns Hopkins University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diagnosis of severe AD (CDR≥3).
Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
Trial design
Design model
Parallel
Treatments tested in this trial
Vestibular physical therapy
BehavioralVestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks.
Active control
BehavioralStrength and flexibility exercises that do not involve head movements.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Vestibular therapyExperimental treatment 1 intervention
Group B: Active controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participant falls
Incidence of falls over a 1-year follow-up period
Time frame
1 yearSponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov