METHODS: 33 persons 20-80 years of age, at least 6 months post stroke with moderate to mild hemiparesis were randomized using a random number generator into the two groups. They were tested using the Action Research Arm Test, Upper Extremity Fugl Meyer Assessment, Stroke Impact Scale and Intrinsic Motivation Inventory pre and post training. Adherence was measured using timestamps generated by the gaming system. Subjects had the Home Virtual Rehabilitation System (Qiu in J Neuroeng Rehabil 17: 1-10, 2020) placed in their homes and were taught to perform rehabilitation games using it. Subjects were instructed to train twenty minutes per day but were allowed to train as much as they chose. Subjects trained for 12 weeks without appointments and received intermittent support from study staff. Group outcomes were compared using ANOVA. Correlations between subject demographics and adherence, as well as motor outcome, were evaluated using Pearson Correlation Coefficients.
RESULTS: There were 5 dropouts and no adverse events. The main effect of time was statistically significant for four of the five clinical outcome measures. There were no significant training group by time interactions. Measures of adherence did not differ significantly between groups. The combined groups improved their UEFMA scores on average by 5.85 (95% CI 4.73-6.98). 21 subjects from both groups demonstrating improvements in UEFMA scores of at least 5 points, exceeding the minimal clinically important difference of 4.25. IMI scores were stable pre to post training.
CONCLUSIONS: Scaffolding challenges during game based rehabilitation did not elicit higher levels of adherence when compared to algorithm control of game difficulty. Both sparsely supervised programs of game-based treatment in the home were sufficient to elicit statistically significant, clinically meaningful improvements in motor function and activities of daily living.
BACKGROUND: Clinical Trials.gov-NCT03985761, Registered June 14, 2019.
方法:33名20-80岁的人,卒中后至少6个月合并中度至轻度偏瘫采用随机数字发生器随机分为两组.他们使用行动研究手臂测试进行了测试,上肢FuglMeyer评估,培训前后中风影响量表和内在动机量表。使用由游戏系统生成的时间戳来测量粘附性。受试者在家中放置了家庭虚拟康复系统(QiuinJNeuroengRehabil17:1-10,2020),并被教导使用它进行康复游戏。受试者被指示每天训练二十分钟,但被允许训练与他们选择的一样多。受试者在没有预约的情况下接受了12周的培训,并接受了研究人员的间歇性支持。使用方差分析比较组结果。主题人口统计学和依从性之间的相关性,以及运动结果,使用皮尔逊相关系数进行评估。
结果:有5例患者退出,无不良事件。时间的主要影响对于五个临床结果指标中的四个具有统计学意义。在时间互动方面没有明显的训练组。两组之间的依从性测量没有显着差异。合并组的UEFMA得分平均提高了5.85(95%CI4.73-6.98)。两组中有21名受试者证明UEFMA得分至少提高了5分,超过4.25的最小临床重要差异。培训前后IMI得分稳定。
结论:与游戏难度的算法控制相比,基于游戏的康复过程中的支架挑战并未引起更高的依从性。在家中进行基于游戏的治疗的两个稀疏监督程序都足以引起统计学上的显着影响,临床上有意义的运动功能和日常生活活动的改善。
背景:临床试验.gov-NCT03985761,2019年6月14日注册。