The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.
The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.
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DOI：
10.1186/1471-2377-13-71
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发表时间：
2013-07-02
期刊：
影响因子：
2.6
通讯作者：
Barker RN
中科院分区：
文献类型：
--
作者：
Brauer SG;Hayward KS;Carson RG;Cresswell AG;Barker RN
脑卒中后上肢功能恢复差。脑卒中后急性-亚急性期是促进上肢功能恢复的最佳时间窗。然而，在此阶段常规提供的训练的剂量和内容不太可能足以驱动功能恢复，特别是在存在严重运动障碍的情况下。目前的研究涉及一种通过评估SMART臂来解决这一缺陷的方法，SMART臂是一种非机器人器械，能够让患有严重上肢残疾的卒中幸存者进行密集和重复的伸手练习，目的是改善上肢功能。将比较SMART手臂训练（有或没有结果触发电刺激（OT-stim））以增强运动和常规治疗的结局与单独常规治疗的结局。正在进行一项前瞻性、评估者设盲、平行、三组随机对照试验。将从住院康复机构招募75名首次单侧卒中不到4个月的受试者，这些受试者存在严重手臂残疾（运动评估量表[MAS]项目6上可能的6分中的3分或更少）。受试者将被随机分配到三个剂量匹配组中的一个：使用OT-stim和常规治疗的SMART Arm训练;不使用OT-stim和常规治疗的SMART Arm训练;或仅使用常规治疗。所有参与者将在四周内接受20小时的上肢训练。设盲评估员将进行4次评估：干预前（0周）、干预后（4周）、26周和52周随访。主要结局指标为MAS项目6。所有分析将基于意向治疗原则。通过在住院康复期间对功能性上肢任务进行密集和重复练习，SMART Arm训练（有或没有OT-stim）与常规治疗相结合，有可能改善重度运动残疾患者的上肢功能恢复。将探讨SMART手臂训练对上肢损伤、活动和参与的即时和长期影响，以及与单独常规治疗相比，使用或不使用OT-stim进行训练以增强运动的益处。ACTRN12608000457347
Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone. ACTRN12608000457347
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