BACKGROUND:Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined. METHODS:This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL). DISCUSSION:This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02631850 .

译文

背景:约束诱导运动疗法(CI疗法)被证明可以减少残疾,增加受影响的手臂/手的使用,并促进卒中后上肢偏瘫的患者的大脑可塑性。随机对照试验始终证明,CI疗法优于其他康复范例,但只有大约120万患有上肢残疾的慢性卒中幸存者中的一小部分可以使用CI疗法。当前的研究旨在建立一种以患者为中心的新型康复方法的相对有效性,该方法利用新开发的,廉价的和可商购的游戏技术将CI疗法传播给服务欠缺的个人。 CI疗法的视频游戏交付将与传统的基于临床的CI疗法和标准的上肢康复进行比较。另外,将检查对一种治疗方法与另一种治疗方法有不同影响的个体因素。
方法:本方案概述了采用平行分组设计的多站点随机对照试验。将在四个地点招募24名患有中风后慢性偏瘫的成年人。参与者被随机分为四个研究组之一:(1)传统的基于临床的CI治疗;(2)作为治疗师的顾问视频游戏CI疗法;(3)作为治疗师的顾问视频游戏CI疗法,并通过其他治疗师联系远程康复/视频咨询,以及(4)标准的上肢康复。经过6个月的随访,分配给标准上肢康复条件的患者转入独立的视频游戏CI治疗,然后进行治疗师咨询。所有干预措施均在三个星期内完成。主要结局指标包括通过沃尔夫运动功能测试(WMFT)进行的运动改善,通过运动活动日志(MAL)进行的日常活动的手臂使用质量以及通过神经系统疾病的生活质量进行的生活质量评估( NeuroQOL)。
讨论:该多站点RCT旨在确定基于家庭技术的CI疗法与标准上肢康复和诊所CI疗法的比较效果。该研究设计还可以在以博弈和技术为基础的康复治疗师-顾问模型中评估治疗师接触时间对治疗结果的影响。
试用注册:Clinicaltrials.gov,NCT02631850。

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