TY - JOUR
T1 - Vestibular therapy to reduce falls in people with Alzheimer’s disease
T2 - study protocol for a pilot randomized controlled trial
AU - Yesantharao, Lekha V.
AU - Rosenberg, Paul
AU - Oh, Esther
AU - Leoutsakos, Jeannie
AU - Munro, Cynthia A.
AU - Agrawal, Yuri
N1 - Funding Information:
This study is funded by the National Institute on Aging (NIA), Grant R01AG065259-01A1. The NIA was involved in overseeing and approving the Data Safety and Monitoring Board charter and membership for the study.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Falls 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. Methods: The 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 registration: ClinicalTrial.Gov identifier — NCT03799991. Registered 01 August 2019.
AB - Background: Falls 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. Methods: The 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 registration: ClinicalTrial.Gov identifier — NCT03799991. Registered 01 August 2019.
KW - Alzheimer’s disease
KW - Fall-related injury
KW - Vestibular rehabilitation
KW - Vestibular therapy
UR - http://www.scopus.com/inward/record.url?scp=85135274570&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85135274570&partnerID=8YFLogxK
U2 - 10.1186/s40814-022-01133-w
DO - 10.1186/s40814-022-01133-w
M3 - Article
C2 - 35918757
AN - SCOPUS:85135274570
SN - 2055-5784
VL - 8
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 167
ER -