[论文解读] A wearable anti-gravity supplement to therapy does not improve arm function in chronic stroke: a randomized trial

Courtney Celian, Partha Ryali+3 more|arXiv (Cornell University)|May 7, 2024

Stroke Rehabilitation and RecoveryMedicine被引用 3

一句话总结

这项随机对照试验评估了在慢性卒中患者中，将ExoNET可穿戴抗重力装置作为职业治疗的补充疗法。尽管该装置安全且可行，并在Box and Blocks测试中显示出显著改善（效应量：2.1，p = .04），但在ARAT评分或其他主要临床指标上，两组之间未发现显著差异，提示其在上肢功能恢复方面整体疗效有限。

ABSTRACT

Background: Gravity confounds arm movement ability in post-stroke hemiparesis. Reducing its influence allows effective practice leading to recovery. Yet, there is a scarcity of wearable devices suitable for personalized use across diverse therapeutic activities in the clinic. Objective: In this study, we investigated the safety, feasibility, and efficacy of anti-gravity therapy using the ExoNET device in post-stroke participants. Methods: Twenty chronic stroke survivors underwent six, 45-minute occupational therapy sessions while wearing the ExoNET, randomized into either the treatment (ExoNET tuned to gravity-support) or control group (ExoNET tuned to slack condition). Clinical outcomes were evaluated by a blinded-rater at baseline, post, and six-week follow-up sessions. Kinetic, kinematic, and patient experience outcomes were also assessed. Results: Mixed-effect models showed a significant improvement in Box and Blocks scores in the post-intervention session for the treatment group (effect size: 2.1, p = .04). No significant effects were found between the treatment and control groups for ARAT scores and other clinical metrics. Direct kinetic effects revealed a significant reduction in muscle activity during free exploration with an effect size of (-7.12%, p< 005). There were no significant longitudinal kinetic or kinematic trends. Subject feedback suggested a generally positive perception of the anti-gravity therapy. Conclusions: Anti-gravity therapy with the ExoNET is a safe and feasible treatment for post-stroke rehabilitation. The device provided anti-gravity forces, did not encumber range of motion, and clinical metrics of anti-gravity therapy demonstrated improvements in gross manual dexterity. Further research is required to explore potential benefits in broader clinical metrics.

研究动机与目标

• 评估在慢性卒中患者中使用ExoNET装置进行可穿戴抗重力治疗的安全性和可行性。
• 评估在职业治疗过程中提供抗重力辅助是否能改善慢性卒中患者的上肢功能。
• 比较使用重力支持模式与松弛状态的参与者在临床、动力学和运动学结果上的差异。
• 考察患者对抗重力治疗装置的主观体验和感知。

提出的方法

• 将20名慢性卒中患者随机分为治疗组（ExoNET调节为重力支持模式）或对照组（ExoNET处于松弛状态）。
• 参与者在为期3周的时间内完成六次每次45分钟的职业治疗。
• 通过标准化评估测量临床结局，包括Box and Blocks测试和Action Research Arm Test（ARAT），由盲法评估者在基线、干预后及6周随访时进行评估。
• 在自由探索任务期间收集动力学和运动学数据，以评估肌肉活动和运动模式。
• 收集受试者反馈，以评估用户体验和对设备的感知。
• 采用混合效应模型分析临床和生理结局的纵向变化。

实验结果

研究问题

• RQ1 与标准治疗相比，使用ExoNET装置进行可穿戴抗重力治疗是否能显著改善慢性卒中患者的上肢功能？
• RQ2 ExoNET装置在临床环境中进行职业治疗时是否安全且可行？
• RQ3 在抗重力辅助期间，肌肉活动或运动学是否出现可测量的变化？
• RQ4 患者对设备的感知是否与临床或动力学改善相关？
• RQ5 干预结束后6周，上肢功能的改善是否具有持续性？

主要发现

• 治疗组在干预后Box and Blocks评分出现统计学上显著改善（效应量：2.1，p = .04）。
• 在ARAT评分或其他主要临床指标上，两组之间未观察到显著差异。
• 在自由探索期间，治疗组的肌肉活动显著减少（效应量：-7.12%，p < .005）。
• 在整个研究期间，动力学或运动学数据中未发现显著的纵向趋势。
• 参与者普遍对抗重力治疗及设备的易用性持积极评价。
• ExoNET装置在不限制活动范围的情况下提供了有效的抗重力辅助，支持其在临床应用中的可行性。