Rodgers Helen, Shaw Lisa, Bosomworth Helen, Aird Lydia, Alvarado Natasha, Andole Sreeman, Cohen David L, Dawson Jesse, Eyre Janet, Finch Tracy, Ford Gary A, Hislop Jennifer, Hogg Steven, Howel Denise, Hughes Niall, Krebs Hermano Igo, Price Christopher, Rochester Lynn, Stamp Elaine, Ternent Laura, Turner Duncan, Vale Luke, Warburton Elizabeth, van Wijck Frederike, Wilkes Scott
Stroke Research Group, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.
Trials. 2017 Jul 20;18(1):340. doi: 10.1186/s13063-017-2083-4.
Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke.
METHODS/DESIGN: Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation.
NHS stroke services.
adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment.
upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation.
upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial.
allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points.
The results from this trial will determine whether robot-assisted training improves upper limb function post stroke.
ISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013.
手臂功能丧失是中风常见且令人痛苦的后果。我们描述了一项实用的多中心随机对照试验方案，以确定机器人辅助训练是否能改善中风后的上肢功能。
方法/设计：研究设计：实用的三臂多中心随机对照试验、经济分析和过程评估。
英国国家医疗服务体系（NHS）中风服务机构。
首次发生急性或慢性中风（中风后1周-5年）且导致中度至重度上肢功能受限的成年人。随机分组：1. 使用InMotion机器人健身系统进行机器人辅助训练，每次45分钟，每周3次，共12周。2. 强化上肢治疗，每次45分钟，每周3次，共12周。3. 按照当地临床实践接受NHS常规护理。随机化：按中心、中风后的时间以及上肢损伤严重程度对个体参与者进行分层随机化。
随机分组后3个月时，通过动作研究手臂测试（ARAT）测量上肢功能。
3个月和6个月时的上肢损伤（Fugl-Meyer测试）、日常生活活动能力（Barthel日常生活活动指数）、生活质量（中风影响量表、EQ-5D-5L）、资源使用、每质量调整生命年的成本以及不良事件。盲法：由盲法评估者进行结局评估。经济分析：与NHS常规护理相比，对干预措施进行微观成本核算和经济评估。将采用试验内分析和经济模型来推断长期成本和结局。过程评估：对参与者和专业人员进行半结构化访谈，以了解他们对所接受或提供的康复治疗的看法和体验，以及影响试验实施的因素。
考虑到10%的损耗率，720名参与者有80%的把握检测出各治疗组之间成功结局存在15%的差异。成功结局定义：基线ARAT评分为0-7分的必须提高3分或更多；基线ARAT评分为8-13分的提高4分或更多；基线ARAT评分为14-19分的提高5分或更多；基线ARAT评分为20-39分的提高6分或更多。
该试验的结果将确定机器人辅助训练是否能改善中风后的上肢功能。
国际标准随机对照试验编号（ISRCTN），标识符：ISRCTN69371850。于2013年10月4日注册。
