Raess Liliane, Hawe Rachel L, Metzler Megan, Zewdie Ephrem, Condliffe Elizabeth, Dukelow Sean P, Kirton Adam
University Children's Hospital Zurich, Zurich, Switzerland.
Clinical Neurosciences, Alberta Children's Hospital, Calgary, AB, Canada.
Front Rehabil Sci. 2022 Feb 25;3:843767. doi: 10.3389/fresc.2022.843767. eCollection 2022.
To identify challenges of combining robotic upper extremity rehabilitation with tDCS in children with upper extremity bilateral cerebral palsy (CP) by assessing feasibility, tolerability and safety.
This was an unblinded, open-label, pilot clinical trial. Participants completed 10 × 1 h sessions of robotic rehabilitation combined with motor cortex anodal tDCS. Feasibility, acceptability and practicality, were assessed including the number of participants completing the protocol, factors limiting participation, time required for sessions, and completion of functional assessments and tolerability scales. To assess safety, standardized clinical and robotic measures of sensorimotor function were performed. The trial was registered at clinicaltrials.gov (NCT04233710).
Eight children were recruited (mean age 8y ± 1.8y, range 6-11 years) and 5 completed the intervention. There were no serious adverse events. One child developed focal seizures 6 weeks after the trial that were deemed to be unrelated. Barriers to completion included time and scheduling demands and patient factors, specifically cognitive/behavioral impairments and dyskinesia. No decline in clinical function was appreciated.
Robotic upper extremity rehabilitation combined with tDCS may be feasible in children with bilateral CP. Careful participant selection, family engagement, and protocol adaptations are recommended to better understand the feasibility and tolerability of future trials.
通过评估可行性、耐受性和安全性，确定在双侧上肢脑瘫（CP）儿童中联合应用机器人上肢康复和经颅直流电刺激（tDCS）的挑战。
这是一项非盲、开放标签的试点临床试验。参与者完成了10次，每次1小时的机器人康复联合运动皮层阳极tDCS治疗。评估了可行性、可接受性和实用性，包括完成方案的参与者数量、限制参与的因素、治疗所需时间以及功能评估和耐受性量表的完成情况。为评估安全性，进行了感觉运动功能的标准化临床和机器人测量。该试验已在clinicaltrials.gov（NCT04233710）注册。
招募了8名儿童（平均年龄8岁±1.8岁，范围6 - 11岁），5名完成了干预。没有严重不良事件。1名儿童在试验6周后出现局灶性癫痫发作，被认为与此无关。完成治疗的障碍包括时间和日程安排要求以及患者因素，特别是认知/行为障碍和运动障碍。未观察到临床功能下降。
机器人上肢康复联合tDCS在双侧CP儿童中可能是可行的。建议仔细选择参与者、让家庭参与并调整方案，以更好地了解未来试验的可行性和耐受性。
