College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, Middlesex, UK
College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, Middlesex, UK.
BMJ Open. 2022 Jun 7;12(6):e058905. doi: 10.1136/bmjopen-2021-058905.
Upper limb (UL) rehabilitation is most effective early after stroke, with higher doses leading to improved outcomes. For the stroke survivor, the repetition may be monotonous. For clinicians, providing a clinically meaningful level of input can be challenging. As such, time spent engaged in UL activity among subacute stroke survivors remains inadequate. Opportunities for the stroke survivor to engage with UL rehabilitation in a safe, accessible and engaging way are essential to improving UL outcomes following stroke. The NeuroBall is a non-immersive virtual reality (VR) digital system designed for stroke rehabilitation, specifically for the arm and hand. The aim of the Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke study is to determine the safety, feasibility and acceptability of the NeuroBall as a rehabilitation intervention for the UL in subacute stroke.
A feasibility randomised controlled trial (RCT) will compare the NeuroBall plus usual care with usual care only, in supporting UL rehabilitation over 7 weeks. Twenty-four participants in the subacute poststroke phase will be recruited while on the inpatient or early supported discharge (ESD) stroke pathway. Sixteen participants will be randomised to the intervention group and eight to the control group. Outcomes assessed at baseline and 7 weeks include gross level of disability, arm function, spasticity, pain, fatigue and quality of life (QoL). Safety will be assessed by recording adverse events and using pain, spasticity and fatigue scores. A parallel process evaluation will assess feasibility and acceptability of the intervention. Feasibility will also be determined by assessing fidelity to the intervention. Postintervention, semistructured interviews will be used to explore acceptability with 12 participants from the intervention group, four from the usual care group and with up to nine staff involved in delivering the intervention.
This trial has ethical approval from Brunel University London's Research Ethics Committee 25257-NHS-Oct/2020-28121-2 and the Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales) REC ref: 20/WA/0347. The study is sponsored by Brunel University London.
Dr Derek Healy, Chair, University Research Ethics committee (Derek.healy@brunel.ac.uk). Trial results will be submitted for publication in peer-reviewed journals, presented at national and international conferences and distributed to people with stroke.
ISRCTN11440079; Pre-results.
上肢（UL）康复在中风后早期最有效，剂量越高，结果越好。对于中风幸存者来说，重复可能很单调。对于临床医生来说，提供有临床意义的投入水平具有挑战性。因此，亚急性中风幸存者参与上肢活动的时间仍然不足。为了改善中风后的上肢结果，中风幸存者有机会以安全、可及和吸引人的方式参与上肢康复至关重要。NeuroBall 是一种非沉浸式虚拟现实（VR）数字系统，专为中风康复设计，特别是针对手臂和手部。使用虚拟游戏进行康复治疗用于医院和家庭的上肢后中风训练研究的目的是确定 NeuroBall 作为亚急性中风后上肢康复干预措施的安全性、可行性和可接受性。
一项可行性随机对照试验（RCT）将比较 NeuroBall 加常规护理与仅常规护理，以支持上肢康复治疗 7 周。将在住院或早期支持出院（ESD）中风通路期间招募 24 名亚急性中风后阶段的参与者。16 名参与者将被随机分配到干预组，8 名参与者分配到对照组。基线和 7 周时评估的结果包括残疾的总水平、手臂功能、痉挛、疼痛、疲劳和生活质量（QoL）。通过记录不良事件并使用疼痛、痉挛和疲劳评分来评估安全性。平行过程评估将评估干预的可行性和可接受性。还将通过评估对干预措施的保真度来确定可行性。干预后，将使用半结构化访谈探索 12 名干预组参与者、4 名常规护理组参与者以及最多 9 名参与干预措施的工作人员的可接受性。
本试验已获得伦敦布鲁内尔大学研究伦理委员会 25257-NHS-Oct/2020-28121-2 和威尔士研究伦理委员会 5 班戈（威尔士健康和护理研究委员会）的伦理批准 REC ref:20/WA/0347。该研究由伦敦布鲁内尔大学赞助。
Derek Healy 博士，大学研究伦理委员会主席（Derek.healy@brunel.ac.uk）。试验结果将提交给同行评议期刊发表，在国内外会议上报告，并分发给中风患者。
ISRCTN11440079；预结果。
