Johnson Liam, Bird Marie-Louise, Muthalib Makii, Teo Wei-Peng
Stroke Division, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.
Faculty of Health Sciences, Australian Catholic University, Melbourne, Australia.
BMJ Open. 2018 Jan 9;8(1):e018388. doi: 10.1136/bmjopen-2017-018388.
The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.
In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Scale, and the will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.
The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.
ACTRN12617000745347; Pre-results.
中风交互式虚拟疗法（STRIVE）干预措施通过在线平台，为居住在社区的中风幸存者提供个性化的、远程监督的渐进性运动训练。本试验旨在确定STRIVE干预措施对居住在社区的中风幸存者的临床疗效及其对大脑活动的影响。
在一项多中心、评估者盲法随机对照试验中，将招募60名中风后3个月以上、上肢有轻度至中度损伤的幸存者，并按地点（墨尔本、维多利亚或朗塞斯顿、塔斯马尼亚）平均随机分组，在当地运动训练设施接受8周的虚拟疗法（VT）或常规护理。分配到VT组的参与者将根据其损伤严重程度和偏好进行3 - 5项上肢运动，而分配到常规护理组的参与者将被要求维持其日常活动。主要结局指标将是上肢运动功能和损伤，分别使用动作研究臂测试和上肢Fugl - Meyer评估。次要结局指标包括上肢功能和痉挛，分别通过箱块测试和改良Ashworth量表测量，以及通过功能性近红外光谱测量在伸手和手腕伸展运动期间双侧感觉运动皮层血流动力学的任务相关变化。生活质量将使用该量表进行测量，并且将使用该量表来测量偏瘫手臂的使用情况。所有测量将在基线和干预后立即进行评估。
该研究于2017年5月获得迪肯大学人类研究伦理委员会批准（编号2017 - 087）。研究结果将在同行评审期刊上发表，并在主要的国际中风会议上展示。
ACTRN12617000745347；预结果。
