Providence Veterans Affairs Medical Center and Brown University, Providence, RI 02909, USA.
N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
Effective rehabilitative therapies are needed for patients with long-term deficits after stroke.
In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.
At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.
In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)
对于中风后长期存在缺陷的患者，需要有效的康复治疗。
在这项涉及 127 名中风后 6 个月或以上中度至重度上肢损伤患者的多中心、随机、对照试验中，我们将 49 名患者随机分配接受强化机器人辅助治疗，50 名患者接受强化比较治疗，28 名患者接受常规护理。治疗包括 36 个 1 小时疗程，持续 12 周。主要结局是中风后运动功能恢复的 Fugl-Meyer 评估在 12 周时的变化。次要结局是 Wolf 运动功能测试和中风影响量表的评分。次要分析评估了 36 周时的治疗效果。
在 12 周时，接受机器人辅助治疗的患者的 Fugl-Meyer 评分均值优于接受常规护理的患者（差值为 2.17 分；95%置信区间 [CI]，-0.23 至 4.58），且优于接受强化比较治疗的患者（差值为-0.14 分；95%CI，-2.94 至 2.65），但差异无统计学意义。接受机器人辅助治疗的患者的中风影响量表评分明显优于接受常规护理的患者（差值为 7.64 分；95%CI，2.03 至 13.24）。其他治疗比较在 12 周时均无显著差异。次要分析显示，在 36 周时，机器人辅助治疗与常规护理相比，显著改善了 Fugl-Meyer 评分（差值为 2.88 分；95%CI，0.57 至 5.18）和 Wolf 运动功能测试的用时（差值为-8.10 秒；95%CI，-13.61 至-2.60），但与强化治疗相比则无显著差异。未报告严重不良事件。
在中风后长期存在上肢缺陷的患者中，与常规护理或强化治疗相比，机器人辅助治疗在 12 周时并未显著改善运动功能。在次要分析中，与常规护理相比，机器人辅助治疗在 36 周时改善了结局，但与强化治疗相比则无显著差异。（临床试验注册编号，NCT00372411。）
