Robot-assisted therapy for long-term upper-limb impairment after stroke.
Robot-assisted therapy for long-term upper-limb impairment after stroke.
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DOI：
10.1056/nejmoa0911341
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发表时间：
2010-05-13
期刊：
影响因子：
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通讯作者：
Peduzzi P
中科院分区：
文献类型：
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作者：
Lo AC;Guarino PD;Richards LG;Haselkorn JK;Wittenberg GF;Federman DG;Ringer RJ;Wagner TH;Krebs HI;Volpe BT;Bever CT Jr;Bravata DM;Duncan PW;Corn BH;Maffucci AD;Nadeau SE;Conroy SS;Powell JM;Huang GD;Peduzzi P
对于中风后长期功能障碍的患者，需要有效的康复治疗。在这项涉及127名中风后6个月或以上的中重度上肢损伤患者的多中心随机对照试验中，我们随机分配49名患者接受强化机器人辅助治疗，50名接受强化对照治疗，28名接受常规护理。治疗包括36次1小时的疗程，为期12周。主要结果是在12周时，根据Fugl-Meyer对中风后感觉运动恢复的评估，运动功能发生了变化。次要结果是Wolf运动功能测试和中风影响量表的分数。二次分析在36周时评估治疗效果。12周时，接受机器人辅助治疗的患者的平均Fugl-Meyer评分好于接受常规护理的患者(差异2.17分；95%可信区间[−]0.23~4.58)，而差于接受强化对照治疗的患者(差异−0.14分；95%CI，−2.94~2.65)，但差异无统计学意义。接受机器人辅助治疗的患者在卒中影响量表上的结果明显好于接受常规护理的患者(差异7.64分；95%CI，2.03至13.24)。在12周时，没有其他治疗比较有意义。二次分析显示，在36周时，机器人辅助治疗与常规治疗相比，显著改善了Fugl-Meyer评分(差值2.88分；95%可信区间，0.57至5.18)和沃尔夫运动功能测试时间(差值，−8.10秒；95%可信区间，−13.61至−2.60)，但与强化治疗组相比无显著差异。没有严重不良反应的报道。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。在二次分析中，与常规护理相比，机器人辅助治疗在36周内改善了结果，但与强化治疗相比没有改善。(ClinicalTrials.gov编号，NCT00372411。)
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.)