Data_Sheet_1_Modulated effectiveness of rehabilitation motivation by reward strategies combined with tDCS in stroke: study protocol for a randomized controlled trial.docx

BackgroundStroke survivors often exhibit low motivation for rehabilitation, hindering their ability to effectively complete rehabilitation training task effectively and participate in daily activities actively. Reward strategies have been identified as an effective method for boosting rehabilitation motivation, but their long-term efficacy remains uncertain. Transcranial direct current stimulation (tDCS) has been recognized as a technique that facilitates plastic changes and functional reorganization of cortical areas. Particularly, tDCS can improve the functional connectivity between brain regions associated with goal-directed behavior when applied to the left dorsolateral prefrontal cortex (dlPFC). Combing reward strategies with tDCS (RStDCS) has been shown to motivate healthy individuals to exert more effort in task performance. However, research exploring the combined and sustained effects of these strategies on rehabilitation motivation in stroke survivors is lacking.
Methods and designEighty-seven stroke survivors with low motivation and upper extremity dysfunction will be randomized to receive either conventional treatment, RS treatment, or RStDCS treatment. The RStDCS group will receive reward strategies combined with anodal tDCS stimulation of the left dlPFC. The RS group will receive reward strategies combined with sham stimulation. The conventional group will receive conventional treatment combined with sham stimulation. tDCS stimulation is performed over 3 weeks of hospitalization, 20 min/time, five times a week. Reward strategies refers to personalized active exercise programs for patients during hospitalization and at home. Patients can voluntarily choose tasks for active exercise and self-report to the therapist so as to punch a card for points and exchange gifts. The conventional group will receive home rehabilitation instructions prior to discharge. Rehabilitation motivation, measured using RMS. RMS, FMA, FIM, and ICF activity and social engagement scale will be compared at baseline, 3 weeks, 6 weeks, and 3 months post-enrollment to evaluate patients’ multifaceted health condition based on the ICF framework.
DiscussionThis study integrates knowledge from social cognitive science, economic behavioral science, and other relevant fields. We utilize straightforward and feasible reward strategies, combined with neuromodulation technology, to jointly improve patients’ rehabilitation motivation. Behavioral observations and various assessment tools will be used to monitor patients’ rehabilitation motivation and multifaceted health condition according to the ICF framework. The aim is to provide a preliminary exploration path for professionals to develop comprehensive strategies for improving patient rehabilitation motivation and facilitating a complete “hospital—home—society” rehabilitation process.
Clinical trial registrationhttps://www.chictr.org.cn/showproj.aspx?proj=182589, ChiCTR2300069068

背景
脑卒中幸存者常表现出较低的康复动机，这会阻碍其有效完成康复训练任务并积极参与日常活动的能力。奖励策略已被证实是提升康复动机的有效手段，但其长期疗效仍不明确。经颅直流电刺激（transcranial direct current stimulation, tDCS）是一种可促进皮层区域可塑性变化与功能重组的技术。尤其当刺激左侧背外侧前额叶皮层（left dorsolateral prefrontal cortex, dlPFC）时，tDCS可增强与目标导向行为相关的脑区间功能连接。将奖励策略与tDCS联合应用（Reward strategies combined with tDCS, RStDCS）已被证明可激励健康个体在任务执行中付出更多努力，但目前尚缺乏针对该联合策略对脑卒中幸存者康复动机的综合及持续影响的相关研究。

方法与设计
本研究将87例存在低康复动机且上肢功能障碍的脑卒中幸存者随机分为三组，分别接受常规治疗、奖励策略（Reward Strategies, RS）治疗以及联合奖励策略与tDCS的RStDCS治疗。其中，RStDCS组将接受奖励策略联合左侧dlPFC阳极tDCS刺激；RS组将接受奖励策略联合假刺激；常规治疗组将接受常规治疗联合假刺激。
tDCS刺激将在患者住院期间进行，共3周，每次20分钟，每周5次。奖励策略指为患者制定的住院期间及居家个性化主动运动方案：患者可自主选择主动运动任务，并向治疗师自行申报，以此打卡获得积分并兑换礼品。常规治疗组将在出院前接受居家康复指导。
本研究将采用康复动机量表（Rehabilitation Motivation Scale, RMS）评估患者康复动机，并在基线、入组后3周、6周及3个月时，对比RMS、Fugl-Meyer评估量表（Fugl-Meyer Assessment, FMA）、功能独立性评定量表（Functional Independence Measure, FIM）以及国际功能、残疾和健康分类（International Classification of Functioning, Disability and Health, ICF）活动与社会参与量表的评分结果，基于ICF框架全面评估患者的多维度健康状况。

讨论
本研究整合了社会认知科学、经济行为科学及其他相关领域的研究成果。我们采用简便可行的奖励策略，结合神经调控技术，共同提升患者的康复动机。本研究将通过行为观察及多种评估工具，基于ICF框架监测患者的康复动机与多维度健康状况，旨在为临床从业者制定改善患者康复动机、推动完整“医院—居家—社会”康复流程的综合策略提供初步探索路径。

临床试验注册：https://www.chictr.org.cn/showproj.aspx?proj=182589，ChiCTR2300069068