OBJECTIVE: This review aimed to comprehensively analyze and summarize the clinical evidence from randomized controlled trials (RCTs) regarding the therapeutic effects of commonly used assistive devices on upper extremity function in patients with stroke.
METHODS: To evaluate assistive devices for patients with stroke, we summarized qualitatively throughout synthesis of results, such as therapeutic intervention, intensity, outcome, and summary of results, and examined risk of bias, heterogeneity, mean difference, 95% confidence interval, and I-squared value. To analyze, we used RoB 2 and RevMan 5.4.
RESULTS: The qualitative synthesis included 31 RCTs. The randomization process and the reporting of results showed minimal bias, but there were issues with bias from intended interventions, and missing outcome data presented some concerns. The quantitative synthesis included 16 RCTs. There was a significant difference in the Fugl-Meyer assessment-upper extremity functioning (FMA-UE) scores between the groups, with a total mean difference (95% confidence interval) of 2.40 (0.21, 4.60), heterogeneity values were Tau2 = 0.32, chi-square = 8.22, degrees of freedom = 8 (p = 0.41), and I2 = 3% for FMA-UE and the test for the overall effect produced Z = 2.14 (p = 0.03) in patients with chronic stroke. However, there was no significant difference in all other outcome measures.
CONCLUSIONS: Upper-limb robots did not demonstrate significant superiority over conventional treatments in improving function of upper limbs, with the exception of FMA-UE scores for patients with chronic stroke. The mean difference of FMA-UE was also lower than minimally important difference. Nonetheless, the usage of upper-limb robots may contribute to enhanced function for patients with stroke, as those devices support clinicians and enable a greater number of movement repetitions within specific time frames.
目的:本文旨在全面分析和总结常用辅助器具对脑卒中患者上肢功能影响的随机对照试验(RCTs)的临床证据。
方法:为了评估中风患者的辅助设备,我们在整个结果综合中定性地总结,比如治疗干预,强度,结果,和结果总结,并检查了偏见的风险,异质性,平均差异,95%置信区间,和I平方值。为了分析,我们使用了RoB2和RevMan5.4。
结果:定性合成包括31项随机对照试验。随机化过程和结果报告显示最小的偏差,但是预期的干预措施存在偏见,缺失的结果数据带来了一些担忧。定量合成包括16个RCT。两组之间的Fugl-Meyer评估上肢功能(FMA-UE)评分存在显着差异,总平均差(95%置信区间)为2.40(0.21,4.60),异质性值为Tau2=0.32,卡方=8.22,自由度=8(p=0.41),对于FMA-UE,I2=3%,对总体效果的测试在慢性中风患者中产生Z=2.14(p=0.03)。然而,所有其他结局指标均无显著差异.
结论:上肢机器人在改善上肢功能方面与常规治疗相比没有显著优势,慢性卒中患者的FMA-UE评分除外。FMA-UE的平均差异也低于最低重要差异。尽管如此,上肢机器人的使用可能有助于增强中风患者的功能,因为这些设备支持临床医生,并在特定时间范围内实现更多的运动重复。