Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068 .

中文翻译：

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针对慢性期卒中后人群平衡和活动能力的特定任务导向训练与其结合手动治疗的可行性：试点随机对照试验的研究方案

大型研究表明，中风是导致成人后天残疾的最相关原因之一。中风幸存者的步行和平衡障碍通常会导致日常活动和社会参与受到限制。以任务为导向的训练 (TOT) 是一种有效的治疗策略，手动疗法 (MT) 已成功用于增强该人群的踝关节灵活性。然而，没有研究在随机对照试验中将 TOT 与其与 MT 的组合进行比较。因此，这项试点研究的目的是探索使用预定义的可行性标准进行全面 RCT 的可行性。次要目的是探索特定 TOT 与组合特定 TOT-MT 与对照组对中风后人群的初步影响。这是一项为期 4 周的前瞻性随机对照平行试点试验方案，该试验针对处于慢性阶段的中风后患者，上踝关节活动受限且平衡和活动能力受损。在使用 1:1:1 分配的德国门诊治疗中心，36 名患者将随机分为三组之一：15 分钟距脚关节 MT 加 30 分钟特定 TOT（A 组）、45 分钟特定 TOT（B 组） ）和对照（C组）。培训将以目标为导向，包括基于日常活动的任务，并使用基于患者技能水平的预定义进展标准来增加难度。除了每周 4 分钟的 20 分钟同步家庭培训课程外，还将提供每周 2 次面对面的干预，为期 4 周。数据将由盲法评估员在基线收集，干预后和 4 周随访。主要结果将通过招募、保留和依从率、依从性、不良事件、跌倒和干预的可接受性来评估可行性。次要结果将是步行速度、单任务和双任务功能移动性、踝关节活动度、残疾和与健康相关的生活质量。提供可行性，本研究的结果将用于计算更大的随机对照试验的样本量，以研究与卒中后对照组相比特定 TOT 和特定 TOT-MT 的影响。德国临床试验注册，DRKS00023068。2020 年 9 月 21 日注册，https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068。保留率和依从率、依从性、不良事件、跌倒和干预的可接受性。次要结果将是步行速度、单任务和双任务功能移动性、踝关节活动度、残疾和与健康相关的生活质量。提供可行性，本研究的结果将用于计算更大的随机对照试验的样本量，以研究与卒中后对照组相比特定 TOT 和特定 TOT-MT 的影响。德国临床试验注册，DRKS00023068。2020 年 9 月 21 日注册，https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068。保留率和依从率、依从性、不良事件、跌倒和干预的可接受性。次要结果将是步行速度、单任务和双任务功能移动性、踝关节活动度、残疾和与健康相关的生活质量。提供可行性，本研究的结果将用于计算更大的随机对照试验的样本量，以研究与卒中后对照组相比特定 TOT 和特定 TOT-MT 的影响。德国临床试验注册，DRKS00023068。2020 年 9 月 21 日注册，https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068。踝关节活动度、残疾和健康相关的生活质量。提供可行性，本研究的结果将用于计算更大的随机对照试验的样本量，以研究与卒中后对照组相比特定 TOT 和特定 TOT-MT 的影响。德国临床试验注册，DRKS00023068。2020 年 9 月 21 日注册，https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068。踝关节活动度、残疾和健康相关的生活质量。提供可行性，本研究的结果将用于计算更大的随机对照试验的样本量，以研究与卒中后对照组相比特定 TOT 和特定 TOT-MT 的影响。德国临床试验注册，DRKS00023068。2020 年 9 月 21 日注册，https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068。