Mugge Winfred, Elstgeest Liset E M, van Ginkel Milan, Pol Lucas, de Lange IJsbrand, Pambakian Nicola, Assis de Souza Alvaro, Helmich Rick C, Kamphuis Daan J
Faculty of Mechanical Engineering, Department of Biomechanical Engineering, Delft University of Technology, Delft, The Netherlands.
Reinier de Graaf Hospital, Reinier Academy, Delft, The Netherlands.
Mov Disord. 2025 Mar;40(3):445-455. doi: 10.1002/mds.30082. Epub 2025 Jan 21.
Essential tremor (ET) is characterized by action tremor of the arms, which can interfere substantially with daily activities. Pharmacotherapy may be ineffective or associated with side effects, and stereotactic surgery is invasive. Hence, new accessible treatment options are urgently needed. An easy-to-use and lightweight orthotic device that exerts joint damping may provide an alternative solution for reducing tremor in daily activities.
Our goal was to assess the efficacy of a novel anti-tremor orthosis (STIL) in reducing clinical and accelerometry measures of distal arm tremor in ET.
In a randomized crossover single-blinded trial in 24 ET patients in a hospital setting, we compared three conditions: no orthosis (baseline), a sham device, and the anti-tremor orthosis (order randomized). The orthosis, but not the sham device, passively damped joints in the forearm. Participants performed seven tasks from the Tremor Research Group Essential Tremor Rating Scale (TETRAS). The two co-primary outcome measures were: clinical tremor severity (video-scored TETRAS) and tremor power (accelerometry). Patient satisfaction was self-assessed using the Dutch Quebec User Evaluation of Satisfaction with assistive Technology. Conditions were compared using Wilcoxon signed-rank tests.
The anti-tremor orthosis significantly reduced TETRAS scores compared to sham and baseline (baseline: 19.0 ± 3.2, sham: 13.7 ± 3.9, orthosis: 9.9 ± 3.6; mean ± standard deviation). Similar effects were observed for tremor power, which was reduced by 87.4% (orthosis vs. baseline) and 59.5% (orthosis vs. sham) across all tasks. A total of 71% of participants were (very) satisfied and 12.5% reported minor adverse events (discomfort/redness of skin).
The anti-tremor orthosis had a clinically relevant tremor-reducing effect in ET in a controlled setting, offering potential for a new treatment to manage ET in daily activities. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
特发性震颤(ET)的特征是手臂动作性震颤,这会严重干扰日常活动。药物治疗可能无效或伴有副作用,而立体定向手术具有侵入性。因此,迫切需要新的可行治疗方案。一种易于使用且轻便的能产生关节阻尼的矫形器械可能为减少日常活动中的震颤提供替代解决方案。
我们的目标是评估一种新型抗震颤矫形器(STIL)在降低ET患者手臂远端震颤的临床和加速度测量指标方面的疗效。
在一家医院对24例ET患者进行的随机交叉单盲试验中,我们比较了三种情况:不使用矫形器(基线)、假装置和抗震颤矫形器(顺序随机)。该矫形器而非假装置可被动阻尼前臂关节。参与者完成了震颤研究组特发性震颤评定量表(TETRAS)中的七项任务。两个共同主要结局指标为:临床震颤严重程度(视频评分TETRAS)和震颤功率(加速度测量)。患者满意度通过荷兰魁北克辅助技术用户满意度评估进行自我评估。使用Wilcoxon符号秩检验比较不同情况。
与假装置和基线相比,抗震颤矫形器显著降低了TETRAS评分(基线:19.0±3.2,假装置:13.7±3.9,矫形器:9.9±3.6;均值±标准差)。在震颤功率方面也观察到类似效果,在所有任务中,与基线相比降低了87.4%,与假装置相比降低了59.5%。共有71%的参与者(非常)满意,12.5%报告有轻微不良事件(皮肤不适/发红)。
在对照环境中,抗震颤矫形器对ET具有临床相关的震颤减轻效果,为日常活动中管理ET的新治疗方法提供了潜力。© 2025作者。《运动障碍》由Wiley Periodicals LLC代表国际帕金森和运动障碍协会出版。