Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial.
Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial.
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前庭疗法减少阿尔茨海默病患者的福尔斯：一项初步随机对照试验的研究方案
DOI：
10.1186/s40814-022-01133-w
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发表时间：
2022-08-02
影响因子：
1.7
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跌倒在阿尔茨海默病（AD）患者中非常常见；每年大约有三分之二的阿尔茨海默病患者患病。跌倒事件是损伤、早期住院和较短生存期的主要驱动因素。平衡和行动障碍是AD患者最重要的跌倒危险因素。前庭治疗（VT）是通过前庭功能改善平衡和跌倒风险的有效康复干预，但不常用于AD。我们希望评估使用VT减少跌倒和改善AD患者平衡功能的可行性，并在目前尚未解决的高水平前庭功能缺陷患者群体中推动使用现有的潜在有益疗法。建议的试点临床试验将是一项平行组随机对照试验。从约翰霍普金斯记忆和阿尔茨海默病治疗中心招募诊断为轻中度AD，年龄≥60岁且有护理者的患者。符合条件的患者将接受前庭测试。前庭功能丧失的患者将被允许参加VT试验。将招募100名伴有前庭功能丧失的AD患者，按1:1的比例随机分为试验的对照组和干预组。所有患者将接受基线平衡和认知评估，随后进行8周的主动控制治疗或VT，包括约25分钟的前庭治疗师办公室会议。将对患者进行跌倒跟踪，并在8周和52周（1年）进行平衡和认知的随访评估，分别评估VT对平衡和认知的潜在短期和长期影响。该试验的主要结果是跌倒、平衡（使用伯格平衡量表和计时上升和前进测试）和认知（使用时钟绘制测试、卡片旋转测试、金钱路线图测试和三角形完成任务）。随着人口老龄化和美国阿尔茨海默病患者人数预计在2050年增长到1400万，管理阿尔茨海默病的下降将继续成为一个关键的公共卫生问题；该试验评估潜在解决方案的可行性。临床试验。政府标识符- NCT03799991。2019年8月1日注册。
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. 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). 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. ClinicalTrial.Gov identifier — NCT03799991. Registered 01 August 2019.