Geerse Daphne J, Hoogendoorn Eva M, van Doorn Pieter F, van Bergem Jara S, van Dam Annejet T, Hardeman Lotte E S, Roerdink Melvyn
Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.
Front Neurol. 2025 Feb 24;16:1512409. doi: 10.3389/fneur.2025.1512409. eCollection 2025.
Physiotherapy in the clinic is highly recommended for improving gait, balance, and fall risk in people with Parkinson's disease. In addition, technology may help boost unsupervised exercise hours at home. Strolll is an augmented-reality (AR) neurorehabilitation platform for delivering gait-and-balance exercises onto AR glasses that can be performed under direct supervision of the therapist in the clinic, but also independently at home. Strolll AR also has the option to integrate AR cueing in gait-and-balance exercises to assist people with more severe mobility impairments in performing the exercises. The objective of this pragmatic randomized controlled trial (RCT) on Strolll AR is to examine its clinical feasibility and effectiveness for improving indicators of gait, balance, and falls risk. A secondary objective is to evaluate procedures for tailoring assistive AR cues.
A total of 100 people with Parkinson's disease (Hoehn and Yahr stages 1-3) with gait and/or balance impairments will participate in this study. This study is a pragmatic RCT in which all participants follow the same procedure. After a baseline assessment (T0), participants will start with a 6-week usual care control period, followed by a midterm assessment (T1). Subsequently, participants will undergo 2 weeks of in-clinic familiarization with Strolll AR. Then, participants will start with the 6-week Strolll AR intervention at home, followed by a final in-clinic assessment (T2). The primary study parameters are feasibility (i.e., safety, adherence, performance, and user experience) and effectiveness for improving indicators of gait, balance, and falls risk. For the statistical analyses on effectiveness, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple ( = 20) randomizations. Recruitment started in May 2024 and the last T2 assessment is expected in February 2025.
The design of this particular pragmatic RCT will demonstrate feasibility and effectiveness in a real-world setting and in a representative population. Strolll AR may facilitate the transition from supervised care in the clinic to independent care at home, providing a platform for delivering individualized treatment, assisted with AR cues when deemed beneficial, for improving gait, balance, and falls risk in people with Parkinson's disease.
https://clinicaltrials.gov/, identifier NCT06590987.
强烈推荐在临床中进行物理治疗，以改善帕金森病患者的步态、平衡能力和跌倒风险。此外，技术可能有助于增加在家中无人监督的锻炼时长。Strolll是一个增强现实（AR）神经康复平台，可在AR眼镜上进行步态和平衡训练，这些训练既可以在临床治疗师的直接监督下进行，也可以在家中独立完成。Strolll AR还可以选择在步态和平衡训练中整合AR提示，以帮助行动障碍更严重的患者进行训练。这项关于Strolll AR的实用随机对照试验（RCT）的目的是检验其在改善步态、平衡和跌倒风险指标方面的临床可行性和有效性。次要目标是评估定制辅助AR提示的程序。
共有100名患有步态和/或平衡障碍的帕金森病患者（Hoehn和Yahr分期为1-3期）将参与本研究。本研究是一项实用RCT，所有参与者遵循相同的程序。在基线评估（T0）后，参与者将开始为期6周的常规护理对照期，随后进行中期评估（T1）。随后，参与者将在诊所接受为期2周的Strolll AR熟悉训练。然后，参与者将开始在家中进行为期6周的Strolll AR干预，随后进行最后一次诊所评估（T2）。主要研究参数是可行性（即安全性、依从性、表现和用户体验）以及改善步态、平衡和跌倒风险指标的有效性。对于有效性的统计分析，将使用多次（=20）随机化将参与者分配到对照组（使用T0-T1变化数据）或干预组（使用T1-T2变化数据）。招募工作于2024年5月开始，预计最后一次T2评估将于2025年2月进行。
这项特定实用RCT的设计将在现实环境和具有代表性的人群中证明可行性和有效性。Strolll AR可能有助于从临床的监督护理过渡到在家中的独立护理，为提供个性化治疗提供一个平台，在认为有益时借助AR提示，以改善帕金森病患者的步态、平衡和跌倒风险。
