Evidence map›Paper›PMID 35918757›Full record

ArticlePilot and feasibility studies2022

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

Lekha V Yesantharao, Paul Rosenberg, Esther Oh, Jeannie Leoutsakos, Cynthia A Munro, Yuri Agrawal

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03799991 (Vestibular Therapy in Alzheimer's Disease), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03799991 narecruitingnot on this map

Vestibular Therapy in Alzheimer's Disease

TypeinterventionalSponsorJohns Hopkins UniversityRan2022 to 2027Enrolled100ConditionsVestibular Diseases, Vestibular Disorder, Alzheimer DiseaseArmsVestibular physical therapy, Active control
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Lekha V YesantharaoDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.ORCID http://orcid.org/0000-0003-3651-716X
Paul RosenbergDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Esther OhDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Jeannie LeoutsakosDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Cynthia A MunroDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Yuri AgrawalDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA. yagrawa1@jhmi.edu.
Johns Hopkins University · US

Funding

Clinical trial of vestibular therapy to reduce falls in patients with Alzheimer's diseaseR01AG065259 · NIA · UNIVERSITY OF COLORADO DENVER · PI AGRAWAL, YURI · 2021 to 2025
$2.4M
NIA NIH HHS 1R01AG065259-01A1NIA NIH HHS R01 AG065259
6 · The paper itself

Abstract

backgroundFalls are highly common in patients with Alzheimer's disease (AD); around two-thirds of AD patients fall annually. Fall events are major drivers of injury, early institutionalization, and shorter survival. Balance and mobility impairment are among the most important fall risk factors in AD patients. Vestibular therapy (VT) is an effective rehabilitation intervention in improving balance and fall risk through vestibular function, but not often used in AD. We want to evaluate the feasibility of using VT to reduce falls and improve balance function in patients with AD and drive use of an existing, potentially beneficial therapy in a patient population whose high level of vestibular deficits is currently unaddressed.

methodsThe proposed pilot clinical trial will be a parallel-group randomized controlled trial. Patients with a diagnosis of mild-moderate AD, age ≥ 60, and the presence of a caregiver will be recruited from the Johns Hopkins Memory and Alzheimer's Treatment Center. Eligible patients will be offered vestibular testing. Patients with vestibular loss will be offered participation in the VT trial. One-hundred AD patients with vestibular loss will be enrolled and randomized 1:1 into the control and intervention arms of the trial. All patients will undergo baseline balance and cognitive assessment, followed by 8 weeks of active control therapy or VT, consisting of ~25-min office sessions with a vestibular therapist. Patients will be tracked for falls and undergo follow-up balance and cognitive assessment at 8 and 52 weeks (1 year) to assess the potential short-term and longer-term effects, respectively, of VT on balance and cognition. The main outcomes of this trial are falls, balance (using the Berg Balance Scale and the Timed Up and Go test), and cognition (using the clock drawing test, the Card Rotations test, the Money Road Map test, and the triangle completion task). DISCUSSION: As the population ages and the number of individuals with AD in the US grows to a projected 14 million in 2050, managing falls in AD will continue to grow as a critical public health concern; this trial assesses feasibility of a potential solution.

trial registrationClinicalTrial.Gov identifier - NCT03799991 . Registered 01 August 2019.

Indexed as

Alzheimer’s diseaseFall-related injuryVestibular rehabilitationVestibular therapy

Identifiers

PMID35918757
PMCPMC9344717
OpenAlexW4289517905

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.