Levin Mindy F, Baniña Melanie C, Frenkel-Toledo Silvi, Berman Sigal, Soroker Nachum, Solomon John M, Liebermann Dario G
School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, QC, Canada.
Center for Interdisciplinary Research in Rehabilitation (CRIR), Montreal, QC, Canada.
Trials. 2018 Jan 4;19(1):7. doi: 10.1186/s13063-017-2377-6.
Recovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved ("active control zone") after identification of a "spasticity zone". Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function.
This single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task.
This study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries.
ClinicalTrials.gov, ID: NCT02725853 . Initially registered on 12 January 2016.
自主运动恢复是主要的康复目标。为确定中风后有效的上肢干预措施所做的努力并不令人满意。本研究包括在虚拟现实（VR）中进行基于个性化损伤的上肢伸展训练，并结合非侵入性脑刺激以增强运动学习。该方法的指导原则是，在识别出“痉挛区”后，将伸展训练限制在保留主动控制的角度区域（“主动控制区”）内。阳极经颅直流电刺激（a-tDCS）用于促进患侧半球的激活并增强半球间平衡。本研究的目的是调查个性化伸展训练（有无a-tDCS）增加主动肘关节控制范围和改善上肢功能的有效性。
这项单盲随机对照试验将在加拿大、印度和以色列的四个学术康复中心进行。干预措施包括为期10天的个性化VR伸展训练，两组接受相同强度的治疗。年龄在25至80岁、患有肘关节痉挛的亚急性中风患者将被随机分为三组之一：接受a-tDCS的个性化训练（在个体确定的主动控制区内伸展）（第1组）或假a-tDCS（第2组），或接受a-tDCS的非个性化训练（无论主动控制区如何都进行伸展）（第3组）。在随机分组时进行基线评估，并在干预结束时和干预后1个月进行两次随访评估。主要结局指标是肘屈肌空间阈值以及痉挛区与肘关节完全伸展范围的比值。次要结局指标包括改良Ashworth量表、Fugl-Meyer评估、简化Wolf运动功能测试以及标准化伸手抓握任务期间的上肢运动学。
本研究将为个性化治疗对痉挛和上肢运动能力的有效性以及在中低收入国家使用低成本干预措施的可行性提供证据。
ClinicalTrials.gov，标识符：NCT02725853。最初于2016年1月12日注册。
