Department of Neurology, Keck School of Medicine (C.W.), University of Southern California, Los Angeles.
Department of Physical Therapy Education and Department of Neurology, SUNY Upstate Medical University, Syracuse, NY (B.K.).
Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
Background and Purpose- For stroke rehabilitation, task-specific training in animal models and human rehabilitation trials is considered important to modulate neuroplasticity, promote motor learning, and functional recovery. Little is known about what constitutes an effective dosage of therapy. Methods- This is a parallel group, 4 arms, single-blind, phase IIb, randomized controlled trial of 4 dosages of arm therapy delivered in an outpatient setting chronically after stroke. Participants were randomized into groups that varied in duration of scheduled therapy (ie, 0, 15, 30, or 60 hours). Forty-one participants completed the study. Planned primary analyses used linear mixed effects regression to model changes from baseline to postintervention in the Motor Activity Log-Quality of Movement rating and the Wolf Motor Function Test time score over 3 weeks of training as a function of therapy dosage. Results- We observed a dose response for the Motor Activity Log-Quality of Movement: the model that included dose and dose by week interaction significantly better fit the data than the model that included week only (log-likelihood test, P=0.0026). In addition, the greater the dosage of training, the greater the change in Motor Activity Log-Quality of Movement, with the dose by week interaction parameter equal to 0.0045 ( P=0.0016; 95% CI, 0.0018-0.0071). Over the 3 weeks of therapy, there was a gain of 0.92 in Motor Activity Log-Quality of Movement for the 60-hour group compared to the 0-hour group. There was no dose response for the Wolf Motor Function Test. Conclusions- For mild-to-moderately impaired stroke survivors, the dosage of patient-centered, task-specific practice systematically influences the gain in quality of arm use but not functional capacity. We caution that we may have been underpowered for the functional capacity outcome. These findings highlight the importance of recovery outcomes that capture arm use in the natural environment. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01749358.
背景与目的-对于中风康复，动物模型中的特定任务训练和人类康复试验被认为对于调节神经可塑性、促进运动学习和功能恢复很重要。但是，对于什么是有效的治疗剂量，我们知之甚少。方法-这是一项平行分组、四臂、单盲、二期 b 期、随机对照试验，在中风后慢性期在门诊环境中进行四种手臂治疗剂量的治疗。参与者被随机分配到治疗时间不同的组（即 0、15、30 或 60 小时）。41 名参与者完成了研究。计划的主要分析使用线性混合效应回归来模拟从基线到干预后的变化，即在 3 周的训练中，运动日志-运动质量评分和 Wolf 运动功能测试时间评分的变化作为治疗剂量的函数。结果-我们观察到运动日志-运动质量的剂量反应：包括剂量和剂量与周交互作用的模型比仅包括周的模型更好地拟合数据（对数似然检验，P=0.0026）。此外，训练剂量越大，运动日志-运动质量的变化越大，剂量与周交互作用参数等于 0.0045（P=0.0016；95%置信区间，0.0018-0.0071）。在 3 周的治疗中，与 0 小时组相比，60 小时组的运动日志-运动质量提高了 0.92。Wolf 运动功能测试没有剂量反应。结论-对于轻度至中度受损的中风幸存者，以患者为中心的特定任务实践的剂量系统地影响手臂使用质量的提高，但不影响功能能力。我们警告说，我们可能对功能能力的结果没有足够的效力。这些发现强调了在自然环境中捕获手臂使用的康复结果的重要性。临床试验注册- URL：https://www.clinicaltrials.gov 。唯一标识符：NCT01749358。
