Technology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic stroke patients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care. In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic stroke participants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes. In total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014). Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance. Trial Registration: ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554 , date of Registration: 13 July 2020.

中文翻译：

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技术支持的坐位平衡疗法与中风后慢性阶段的常规护理：一项试点随机对照试验


坐位平衡疗法和躯干康复的技术开发稀缺。因此，仍然需要进行强化的一对一的治疗师-患者培训。我们开发了一种新颖的康复原型，专门旨在提供坐位平衡疗法。我们调查了技术支持的坐位平衡训练对于慢性中风患者是否可行和安全，并确定与常规护理相比，为期四周的计划后临床结果是否有所改善。在这项平行组、评估者盲法、随机对照试点试验中，我们将首次发生慢性卒中的参与者分为两组。实验组接受常规护理加上康复技术支持的额外治疗，包括 4 周内 12 次每次 50 分钟的治疗。对照组仅接受常规护理。我们在干预前和干预后对所有参与者进行了两次评估。对可行性和安全性进行了描述性分析。组间分析评估了运动和功能结果变化的前后差异。总共招募了 30 名参与者，其中 29 名完成了试验（实验组：n = 14；对照组：n = 15）。基线时没有组间差异。参与者和治疗师评估治疗是否可行。坐位平衡治疗期间没有出现严重不良事件。干预前与干预后临床结果的变化表明，实验组在以下方面比对照组有所提高：坐位平衡和躯干功能，通过躯干损伤量表评估（平均分（SD）7.07（1.69）对比0.33（2.35）） );p < 0.000);最大步态速度，通过 10 米步行测试进行评估（平均步态速度 0.16 (0.16) m/s 与 0.06 (0.06) m/s；p = 0。003）；功能平衡，使用 Berg 平衡量表测量（中位分数 (IQR) 4.5 (5) 对比 0 (4)；p = 0.014）。对慢性中风患者进行技术支持的坐位平衡训练是可行且安全的。在常规护理基础上进行为期 4 周、12 个疗程的计划，表明对躯干功能、最大步态速度和功能平衡有益。试验注册：ClinicalTrials.gov 标识符：NCT04467554，https://clinicaltrials.gov/ct2/show/NCT04467554，注册日期：2020 年 7 月 13 日。