Clinical Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Clinical Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria
BMJ Open. 2022 Jan 4;12(1):e051504. doi: 10.1136/bmjopen-2021-051504.
Stroke rehabilitation guidelines suggest a high-frequency task-oriented training at high intensity. A targeted and self-paced daily training with intermittent supervision is recommended to improve patients' self-management and functional output. So far, there is conflicting evidence concerning the most effective home-training delivery method.
The purpose of this pilot study is to compare the feasibility and preliminary effects of task-oriented home-exercises in patients in the subacute stage after stroke. Twenty-four patients will be randomised (1:1) to a Video group (a) or Paper group (b) of an individualised, task-oriented home-training (50 min, 6×/week, for 4 weeks) based on Wulf and Lewthwaite's Optimizing Performance Through Intrinsic Motivation and Attention for Learning theory of motor learning. Patient-relevant goals will be identified using Goal Attainment Scaling and exercises progressively adapted. Semistructured interviews and a logbook will be used to monitor adherence, arm use and acceptability. Primary outcome will be the feasibility of the methods and a full-scale trial employing predefined feasibility criteria (recruitment, retention and adherence rates, patients' satisfaction with the home-exercise programme and their progress, affected hand use and acceptance of the intervention). Assessed at baseline, post intervention and 4-week follow-up, secondary outcomes include self-perceived hand and arm use, actual upper extremity function and dexterity, hand strength, independence in activities of daily living and health-related quality of life. Interview data will be analysed using qualitative content analysis. Medians (ranges) will be reported for ordinal data, means (SD) for continuous and frequency (percentage) for nominal data.
This study follows the Standard Protocol Items: Recommendations for Interventional Trials-Patient-Reported Outcome (PRO) Extension guideline. Ethical approval was received from the Ethics Committee of the Medical University of Innsbruck, Austria (1304/2020). Written informed consent will be obtained from all participants prior to data collection. Study results will be disseminated to participating patients, patient organisations, via the clinic's homepage, relevant conferences and peer-reviewed journals.
DRKS-ID: DRKS00023395.Study protocol, second revision, 5 December 2021.
中风康复指南建议进行高频、以任务为导向的高强度训练。建议进行有针对性和自我调节的日常训练，并间歇性监督，以提高患者的自我管理和功能输出。到目前为止，关于最有效的家庭训练交付方法，还存在相互矛盾的证据。
本研究旨在比较中风后亚急性期患者进行以任务为导向的家庭锻炼的可行性和初步效果。将 24 名患者随机分为视频组（a）或纸制组（b），每组接受基于 Wulf 和 Lewthwaite 的动机和注意力学习理论的个体化、以任务为导向的家庭训练（50 分钟，每周 6 次，持续 4 周）。使用目标达成量表确定与患者相关的目标，并逐步调整练习。半结构化访谈和日志将用于监测依从性、手臂使用和可接受性。主要结局是方法的可行性和采用预定义可行性标准（招募、保留和依从率、患者对家庭锻炼计划的满意度及其进展、受影响手的使用和对干预的接受程度）的全规模试验。在基线、干预后和 4 周随访时评估，次要结局包括自我感知的手和手臂使用、实际上肢功能和灵巧性、手部力量、日常生活活动的独立性和健康相关生活质量。使用定性内容分析对访谈数据进行分析。对于有序数据，报告中位数（范围）；对于连续数据，报告平均值（标准差）；对于名义数据，报告频率（百分比）。
本研究遵循标准干预试验-患者报告结局（PRO）扩展指南的建议。奥地利因斯布鲁克医科大学伦理委员会已批准该研究（1304/2020）。在收集数据之前，将从所有参与者处获得书面知情同意。研究结果将通过参与患者、患者组织、诊所的主页、相关会议和同行评议期刊进行传播。
DRKS-ID：DRKS00023395.研究方案，第二次修订，2021 年 12 月 5 日。
