Department of Biomedical Science and Engineering, National Central University, Taoyuan, Taiwan.
Department of Computer Science and Information Engineering, National Central University, Taoyuan, Taiwan.
J Int Med Res. 2024 Oct;52(10):3000605241281425. doi: 10.1177/03000605241281425.
Multidisciplinary rehabilitation facilitates post-stroke functional recovery, but is associated with resource and accessibility barriers. This study evaluated the combination of a wearable device-assisted system (WEAR) and conventional therapy for post-stroke rehabilitation.
This randomized, controlled, parallel group, clinical trial was conducted at two rehabilitation centers. A WEAR system was developed featuring sensors and application program-embedded smartphones. Stroke patients within 12 weeks of onset and modified Rankin Scale (mRS) scores of 2 to 4 were randomized into a wearable group (WG, WEAR + conventional rehabilitation) or control group (CG, conventional rehabilitation) for 90 days. The primary outcome was mRS score changes within 90 days.
Among 127 stroke patients enrolled (76 men [59.8%]; mean age: 57.5 years), 63 and 64 patients were randomized to WG and CG, respectively. Both groups showed significant improvements in mRS scores. Between-group repeated measures analysis adjusted for sex, age and number of rehabilitation sessions showed greater improvement in mRS scores within 90 days in the WG than in the CG (estimate: 0.73).
This combined WEAR and conventional rehabilitation approach may improve post-stroke functional recovery compared with conventional rehabilitation alone. The WEAR system permits remote monitoring and recording of rehabilitation in various settings.This clinical trial was retrospectively registered at www.clinicaltrials.gov with the Unique Identifier NCT04997408.
多学科康复有助于脑卒中后的功能恢复，但存在资源和可及性障碍。本研究评估了可穿戴设备辅助系统（WEAR）与常规疗法联合应用于脑卒中康复的效果。
这是一项在两家康复中心开展的随机、对照、平行组临床试验。开发了一种具有传感器和嵌入式智能手机应用程序的 WEAR 系统。发病后 12 周内、改良 Rankin 量表（mRS）评分 2 至 4 分的脑卒中患者被随机分为穿戴组（WG，WEAR+常规康复）或对照组（CG，常规康复），治疗 90 天。主要结局为 90 天内 mRS 评分的变化。
共纳入 127 例脑卒中患者（76 例男性[59.8%]；平均年龄：57.5 岁），63 例和 64 例患者分别被随机分入 WG 和 CG。两组 mRS 评分均显著改善。对性别、年龄和康复次数进行调整的组间重复测量分析显示，WG 在 90 天内 mRS 评分的改善程度大于 CG（估计值：0.73）。
与单纯常规康复相比，WEAR 与常规康复联合应用可能更有助于脑卒中后功能恢复。WEAR 系统可实现远程监测和记录各种环境下的康复情况。本临床试验已在 www.clinicaltrials.gov 网站上进行了回顾性注册，注册号为 NCT04997408。
