Combining specific task-oriented training with manual therapy to improve balance and mobility in patients after stroke: a mixed methods pilot randomised controlled trial

In absence of existing studies, to describe changes in balance and mobility, following specific task-oriented training (TOT), its combination with talocrural manual therapy (MT-TOT) or no intervention, in chronic stroke patients. To explore the feasibility of a full-scale randomised controlled trial (RCT) based on criteria of recruitment, retention and adherence rates, adverse events, falls and acceptability of the intervention. Using an assessor-blinded pilot RCT, 36 stroke patients were allocated to either MT-TOT, TOT, or controls. Supervised interventions were performed 45 min, 2×/weekly, for 4 weeks, and home-based practice 20 min, 4x/weekly for 4 weeks. Qualitative interviews evaluated intervention acceptability. Outcomes of balance, mobility, ankle dorsiflexion range of motion (ROM), falls and health-related quality of life (HRQoL) were assessed at baseline, post-intervention and 4-week follow-up. Preliminary efficacy of MT-TOT and TOT was shown in improving balance (effect size 0.714), walking speed (0.683), mobility (0.265), dual-tasking mobility (0.595), falls (0.037), active and passive talocrural ROM (0.603; 0.751) and activities and social participation related HRQoL domains (0.332–0.784) in stroke patients. The feasibility of a larger RCT was confirmed. Specific MT-TOT and TOT appeared effective and are feasible in stroke patients. A larger RCT is needed to validate the results.<b>Trial Registration:</b> German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00023068 A specific goal- and task-oriented training involving timed mobility and dynamic balance activities based on the demands of daily life, of high intensity and progressed in difficulty according to predefined criteria is feasible in patients after stroke.In this mixed methods pilot study patients indicated high acceptability of task-oriented training with and without ankle mobilisations, with their descriptions being in line with the Theoretical Framework of Acceptability.Specific task-oriented training and its combination with talocrural joint manual therapy improved balance, mobility, talocrural dorsiflexion range of motion and some domains of health-related quality of life in people after stroke. A specific goal- and task-oriented training involving timed mobility and dynamic balance activities based on the demands of daily life, of high intensity and progressed in difficulty according to predefined criteria is feasible in patients after stroke. In this mixed methods pilot study patients indicated high acceptability of task-oriented training with and without ankle mobilisations, with their descriptions being in line with the Theoretical Framework of Acceptability. Specific task-oriented training and its combination with talocrural joint manual therapy improved balance, mobility, talocrural dorsiflexion range of motion and some domains of health-related quality of life in people after stroke.

鉴于现有相关研究的空白，本研究旨在描述慢性脑卒中患者在接受特异性任务导向训练（Task-oriented training, TOT）、踝手法治疗联合任务导向训练（Talocrural manual therapy combined with task-oriented training, MT-TOT）或不进行任何干预后，其平衡与移动能力的变化情况；同时基于招募率、保留率、依从率、不良事件、跌倒情况及干预措施可接受性等标准，探索开展大规模随机对照试验（Randomised Controlled Trial, RCT）的可行性。
本研究采用评估者设盲的先导性随机对照试验设计，将36名脑卒中患者随机分配至MT-TOT组、TOT组及对照组。受试者接受每周2次、每次45分钟的监督式干预训练，持续4周；同时每周进行4次、每次20分钟的家庭训练，同样持续4周。通过质性访谈评估受试者对干预措施的接受度。分别在基线、干预后及4周随访时，对受试者的平衡能力、移动能力、踝背屈活动度（range of motion, ROM）、跌倒情况及健康相关生活质量（Health-related Quality of Life, HRQoL）进行评估。
研究结果显示，MT-TOT与TOT对脑卒中患者存在初步干预效应：可改善平衡能力（效应量0.714）、步行速度（0.683）、移动能力（0.265）、双任务移动能力（0.595）、跌倒发生情况（0.037）、主动与被动踝活动度（0.603；0.751），以及与日常活动及社会参与相关的HRQoL维度（0.332~0.784）。本研究证实了开展大规模RCT的可行性。特异性MT-TOT与TOT方案在脑卒中患者中显示出有效性与可行性，未来需开展大规模RCT以验证本研究结果。

**临床试验注册**：德国临床试验注册库（German Clinical Trials Register），注册号DRKS00023068，注册日期2020年9月21日，注册链接：https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068

基于日常生活需求设计、高强度且可根据预设标准逐步提升难度的特异性目标导向与任务导向训练，包含定时移动与动态平衡活动，在脑卒中后患者中具备可行性。在本混合方法先导性研究中，受试者对联合或不联合踝关节松动术的任务导向训练接受度较高，其访谈内容与可接受性理论框架（Theoretical Framework of Acceptability）相符。特异性任务导向训练及其联合踝关节手法治疗，可改善脑卒中后患者的平衡能力、移动能力、踝背屈活动度以及部分健康相关生活质量维度。

基于日常生活需求设计、高强度且可根据预设标准逐步提升难度的特异性目标导向与任务导向训练，包含定时移动与动态平衡活动，在脑卒中后患者中具备可行性。在本混合方法先导性研究中，受试者对联合或不联合踝关节松动术的任务导向训练接受度较高，其访谈内容与可接受性理论框架（Theoretical Framework of Acceptability）相符。特异性任务导向训练及其联合踝关节手法治疗，可改善脑卒中后患者的平衡能力、移动能力、踝背屈活动度以及部分健康相关生活质量维度。