McNish Reika Nicole, Chembrammel Pramod, Speidel Nathaniel Christopher, Lin Julian Jwchun, López-Ortiz Citlali
Department of Kinesiology and Community Health, Neuroscience Program, Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Chamapign, Urbana, IL, United States.
Health Care Engineering Systems Center, College of Engineering, University of Illinois at Urbana-Champaign, Urbana, IL, United States.
JMIR Res Protoc. 2019 Jan 14;8(1):e11470. doi: 10.2196/11470.
Cerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises.
The aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP.
The protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel.
The trial has not started and is pending local institutional review board approval.
Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.
ClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11470.
脑瘫(CP)是儿童中最常见的发育性运动障碍。脑瘫患者表现出异常的肌张力和运动控制。在脑瘫儿童群体中,4%至17%的人存在张力障碍症状,可能表现为运动任务中的大误差、运动轨迹的高变异性以及静止时的不自主运动。这些肌张力障碍症状通常会随着物理干预练习而加重。
本研究的目的是确定虚拟现实(VR)游戏干预中的触觉反馈对张力障碍型脑瘫儿童运动结果的影响。
该方案描述了一项随机对照试验,使用基于VR游戏的干预措施,并结合全自动机器人触觉反馈。该研究包括在为期6节的基于游戏的干预完成前、后及完成后1个月对运动进行面对面评估。将通过张贴传单和实验室网站招募7至17岁的张力障碍型脑瘫儿童,以及一组同年龄范围的发育正常(TD)儿童参与本研究。我们预计总共招募68名参与者,脑瘫组和TD组各34名。两组儿童将使用区组随机化方法随机分配到干预组或对照组。主要结局指标将是与机器人相互作用力的平滑度指数以及放置在上肢节段的传感器的加速度计信号。次要结局包括一系列临床测试和痉挛的定量测量。实施临床测量的评估人员将处于盲态。所有环节均由研究人员在现场实施。
该试验尚未开始,正在等待当地机构审查委员会的批准。
将检查张力障碍型脑瘫儿童和TD儿童的运动结果在肌肉激活和临床测量方面的变化。将对两组儿童的运动结果分别进行配对t检验。将报告并讨论阳性和阴性结果。
ClinicalTrials.gov NCT03744884;https://clinicaltrials.gov/ct2/show/NCT03744884(由WebCite存档于http://www.webcitation.org/74RSvmbZP)。
国际注册报告识别码(IRRID):PRR1-10.2196/11470。