强化、功能化和游戏化康复方案对上运动神经元损伤患者上肢功能的有效性研究（EnteRtain）：一项多中心随机临床试验。

Effectiveness of an Intensive, Functional, and Gamified Rehabilitation Program on Upper Limb Function in People With Stroke (EnteRtain): A Multicenter Randomized Clinical Trial.

机构信息

Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.

Department of Physiotherapy, SDM Ayurveda Hospital, Udupi, Karnataka, India.

出版信息

Neurorehabil Neural Repair. 2024 Apr;38(4):243-256. doi: 10.1177/15459683231222921. Epub 2024 Jan 29.

DOI:10.1177/15459683231222921

PMID:38284559

Abstract

BACKGROUND1: Despite a growing interest in gaming rehabilitation for upper limb (UL) recovery post-stroke, studies investigating the effects of game-based rehabilitation incorporating functional games are lacking.

OBJECTIVE

To investigate the efficacy of an intensive, functional, gamified rehabilitation program compared to task-based training on UL motor function in acute/sub-acute stroke survivors.

METHODS

This randomized, multicenter, single-blind, clinical trial comprises 120 participants with unilateral stroke who were randomized to receive either gamified training (n = 64) using the ArmAble™ [experimental group (EG)] or task-based training (n = 56) in conjunction with conventional therapy for 2 hours per day, 6 days per week for 2 weeks, followed by UL rehabilitation for another 4 weeks at home. Primary outcomes evaluated by a blinded assessor included the Fugl-Meyer Assessment-Upper Extremity (FM-UE), and Action Research Arm Test (ARAT). Data were analyzed using a linear mixed-effect regression model.

RESULTS

The mean (standard deviation) age of the participants was 54.4 ± 11.7 years (78.1% men) in the EG and 57.7 ± 10.9 years (73.2% men) in the comparator group (CG). The median (interquartile range) time since stroke was 30.0 (54.0) days in the EG and 22.5 (45.0) days in the CG. Following the 2-week intervention, a statistically significant improvement was observed in the EG for the FM-UE [between-group mean differences (95% confidence interval): -3.9 (-6.5, -1.3); = .003]; but not for the ARAT [-2.9 (-5.8, 0.0); = .051]. Gains at 6 weeks were significantly greater in the EG for both FM-UE [-3.9 (-6.5, -1.3); = .003]; and ARAT [-3.0 (-5.9, -0.0); = .046].

CONCLUSION

Gamified rehabilitation using the ArmAble™ device has shown immediate and short-term improvement in UL function after acute/sub-acute stroke.

CLINICAL TRIALS REGISTRY NUMBER

CTRI/2020/09/027651.

摘要

背景 1：尽管人们对游戏康复治疗上肢（UL）卒中后恢复越来越感兴趣，但缺乏研究调查基于功能游戏的游戏康复对 UL 运动功能的影响。

目的

研究强化、功能、游戏化康复方案与基于任务的训练对急性/亚急性卒中幸存者 UL 运动功能的影响。

方法

本随机、多中心、单盲、临床试验纳入了 120 名单侧卒中患者，将其随机分为接受 ArmAble™游戏化训练（实验组，n=64）或结合常规治疗进行基于任务的训练（对照组，n=56），每天 2 小时，每周 6 天，共 2 周，然后在家中进行另外 4 周的 UL 康复治疗。由盲法评估者评估的主要结局包括 Fugl-Meyer 上肢评估（FM-UE）和动作研究上肢测试（ARAT）。使用线性混合效应回归模型进行数据分析。

结果

实验组参与者的平均（标准差）年龄为 54.4±11.7 岁（78.1%为男性），对照组为 57.7±10.9 岁（73.2%为男性）。实验组和对照组的中位（四分位距）卒中后时间分别为 30.0（54.0）天和 22.5（45.0）天。在 2 周干预后，实验组 FM-UE 有显著改善[组间平均差异（95%置信区间）：-3.9（-6.5，-1.3）； = .003]；但 ARAT 无改善[-2.9（-5.8，0.0）； = .051]。实验组在 6 周时 FM-UE [-3.9（-6.5，-1.3）； = .003]和 ARAT [-3.0（-5.9，-0.0）； = .046]的改善均显著大于对照组。