Confounders in rehabilitation trials of task-oriented training: Lessons from the designs of the EXCITE and SCILT multicenter trials
Confounders in rehabilitation trials of task-oriented training: Lessons from the designs of the EXCITE and SCILT multicenter trials
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DOI：
10.1177/1545968306297329
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发表时间：
2007-01-01
影响因子：
4.2
通讯作者：
Dobkin, Bruce H.
中科院分区：
文献类型：
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作者：
Dobkin, Bruce H.
两项多中心随机临床试验 (MRCT)、改善中风后上肢功能的肢体约束诱导治疗评估 (EXCITE) 和使不完全脊髓损伤后功能性行走的脊髓损伤运动试验 (SCILT) 表明，可以在住院或门诊康复期间使用科学方法研究复杂的、面向任务的物理疗法。过去，通过将新疗法与没有治疗或与低强度练习的传统疗法进行比较，可能会高估新疗法的益处。样本量往往太小，可能无法检测新干预措施的功效。此外，虽然结果的统计显着性对于了解一种治疗是否优于另一种治疗至关重要，但结果的临床显着性也必须影响对试验结果的解释。 MRCT设计将通过关注临床前动物模型的局限性而继续改进，这些模型为治疗提供了概念基础，从试验开发每个阶段的丰富策略，到使用适应性方法的更有力的剂量反应研究，通过捕获治疗阶段行为和功能性神经生理学适应的临时测量，旨在进行有临床意义的控制干预，并在可行时包括比率或间隔结果测量，以捕获与日常功能和生活质量增益相关的干预目标。
Two multicenter randomized clinical trials (MRCT), the Extremity Constraint Induced Therapy Evaluation (EXCITE) to improve upper extremity function after stroke and the Spinal Cord Injury Locomotor Trial (SCILT) to enable functional walking after incomplete spinal cord injury, demonstrate that complex, task-oriented physical therapies can be studied using a scientific methodology during inpatient or outpatient rehabilitation. In the past, a new therapy's benefit may have been overestimated by comparing it to no treatment or to a conventional treatment at a low intensity of practice. Sample sizes were often too small and may have failed to detect the efficacy of a new intervention. In addition, whereas statistical significance in outcomes has been critical to understanding whether one treatment is better than another, the clinical significance of outcomes must also impact the interpretation of the results of a trial. MRCT designs will continue to improve through attention to the limitations of preclinical animal models that offer a conceptual basis for the treatment from enrichment strategies at every phase of trial development from more vigorous dose-response studies using adaptive methods by capturing interim measures of behavior and functional neurophysiologic adaptations during the treatment phase by aiming for a clinically meaningful control intervention and by including ratio or interval outcome measures when feasible that capture a target of the intervention in relation to gains in daily functioning and quality of life.