Barzel Anne, Ketels Gesche, Tetzlaff Britta, Krüger Heike, Haevernick Kerstin, Daubmann Anne, Wegscheider Karl, Scherer Martin
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Martinistr, 52, 20246 Hamburg, Germany.
Trials. 2013 Oct 14;14:334. doi: 10.1186/1745-6215-14-334.
Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual').
METHODS/DESIGN: The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order.
A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.
ClinicalTrials.gov NCT01343602.
中风即使在慢性期也会导致持续的康复需求。然而，尽管许多中风患者在初级卫生保健中接受物理或职业治疗，但治疗处方通常未明确规定治疗目标；特别是，在门诊环境中，参与并未被确立为明确的治疗目标。本研究的主要目的是评估一种针对手部或手臂功能受损的慢性中风患者的治疗方案（改良的“家庭约束诱导运动疗法（CIMT）”）在参与日常活动的前提条件方面的疗效：足够的手臂和手部功能。“家庭CIMT”将与传统的物理和职业治疗（“常规治疗”）进行比较。
方法/设计：本研究是一项以治疗机构为聚类的平行聚类随机对照试验（n = 48）。在获得患者（n = 144）的书面同意后，治疗师将被随机分配到干预组或对照组进行治疗。盲法外部评估者将在干预前后以及六个月后使用标准化结局指标对患者进行评估。作为参与前提条件的手臂和手部功能的两个共同主要终点评估指标（定义为在日常生活活动中同等参与度）是运动活动日志（手臂和手部使用质量）和沃尔夫运动功能测试（手臂和手部功能）。这些评估在治疗后四周进行，并相对于基线表现进行对比。主要结局的变化将使用混合模型进行分析，该模型考虑了数据的层次结构，并将根据基线测量值和性别进行调整。主要分析将是两个随机分组在两个共同主要终点各自调整后的平均值方面的比较。为保持总体显著性水平为5%，两个终点将按层次顺序分别在5%的显著性水平进行检验。
CIMT的一种改良方法，即在患者家中可行的“家庭CIMT”，似乎是慢性中风患者门诊护理中一种有前景的治疗方法。若疗效和实用性得到证实，初级保健中将可提供一种以参与为导向的、针对中风的特定治疗方法。
ClinicalTrials.gov NCT01343602。
