Factors associated with clinical meaningful recovery after upper limb task-oriented training in people with stroke: a cohort study

<b>Introduction:</b>This study investigated upper extremity (UE) recovery predictors in post-stroke patients undergoing task-oriented training (TOT) rehabilitation. The data were collected at the Don Gnocchi Foundation hospitals in Italy between 2011 and 2015. Ethical approval was obtained, and all participants provided informed consent.<b>Methods:</b><b>Participants:</b> 64 participants were recruited.<b>Intervention:</b> Participants received 25 sessions of TOT (45 minutes each, five days/week) as an adjunct to standard therapy. TOT focused on functional tasks with real-life objects and was progressively adapted to individual needs.<b>Outcome Measures:</b><b>Fugl-Meyer Assessment - Upper Extremity (FMA-UE):</b> To assess impairment (ICF body function domain).<b>15-item Action Research Arm Test (ARAT-15):</b> To assess activity/performance (ICF activity domain).<b>Quick version of the Disability of the Arm, Shoulder, and Hand questionnaire - 9 items (Q-DASH-9):</b> To assess participation restrictions (ICF participation domain).<b>Predictor Variables:</b> Age, sex (i.e., male, female), dominance of the affected side (affected bodyside; i.e., dominant; non-dominant), chronicity (i.e., chronic; subacute), injury typology (i.e., ischemic; hemorrhagic), injury localization (i.e., cortical; sub-cortical), and baseline scores on the FMA-UE, ARAT-15, and Q-DASH-9.<b>Data Analysis:</b>Descriptive statistics were used to summarize data.Wilcoxon signed-rank test was used to compare pre- and post-intervention scores.Effect sizes were calculated using matched-pairs rank-biserial correlation.Participants were classified as "Responders" or "Non-responders" based on achieving minimally clinically important differences (MCID) in outcome measures.Stepwise binary logistic regression models were developed to identify predictors of responder status. A bidirectional approach was employed, starting with an empty model. Predictors were added (forward selection) or removed (backward elimination) one at a time based on whether their inclusion improved the Akaike information criterion (AIC).Model accuracy was assessed using McFadden’s pseudo-R2, Scaled Brier Score, Receiver Operating Characteristic curve (AUC), and Hosmer–Lemeshow test.Subgroup sensitivity analysis was performed to assess model robustness.<br>

**引言：** 本研究探讨了接受任务导向训练（task-oriented training, TOT）康复的脑卒中后患者的上肢（upper extremity, UE）恢复预测因素。数据收集于2011至2015年间，采集地点为意大利多诺乔基基金会医院。本研究已获得伦理审批，所有参与者均签署了知情同意书。
**方法：**
**研究对象：** 共纳入64名参与者。
**干预方案：** 参与者接受25次任务导向训练（每次45分钟，每周5天），作为常规治疗的辅助手段。任务导向训练聚焦于使用真实物品完成功能性任务，并根据个体需求逐步调整干预方案。
**结局指标：**
- **Fugl-Meyer上肢评估量表（Fugl-Meyer Assessment - Upper Extremity, FMA-UE）：** 用于评估损伤情况，对应国际功能、残疾和健康分类（International Classification of Functioning, Disability and Health, ICF）的身体功能领域。
- **15项动作研究上肢测试（15-item Action Research Arm Test, ARAT-15）：** 用于评估活动表现，对应ICF的活动领域。
- **9条目上肢、肩与手残疾问卷简版（Quick version of the Disability of the Arm, Shoulder, and Hand questionnaire - 9 items, Q-DASH-9）：** 用于评估参与受限情况，对应ICF的参与领域。
**预测变量：** 包括年龄、性别（男/女）、患侧优势性（患侧为优势侧/非优势侧）、病程分期（慢性期/亚急性期）、卒中类型（缺血性/出血性）、卒中部位（皮质型/皮质下型），以及FMA-UE、ARAT-15与Q-DASH-9的基线评分。
**数据分析：** 采用描述性统计对数据进行汇总。使用威尔科克森符号秩检验比较干预前后的评分差异。通过配对秩双列相关系数计算效应量。根据结局指标是否达到最小临床重要差异（minimally clinically important differences, MCID），将参与者划分为“应答者”与“非应答者”。构建逐步二元逻辑回归模型以识别应答状态的预测因素，采用双向建模策略：从空模型出发，根据是否改善赤池信息准则（Akaike information criterion, AIC），逐个添加（向前选择）或移除（向后剔除）预测变量。采用麦克法登伪R²（McFadden’s pseudo-R²）、标化布里尔分数（Scaled Brier Score）、受试者工作特征曲线下面积（Receiver Operating Characteristic curve, AUC）以及霍斯默-莱梅肖检验（Hosmer–Lemeshow test）评估模型准确性。开展亚组敏感性分析以验证模型的稳健性。