Graser Judith V, Bastiaenen Caroline H G, Keller Urs, van Hedel Hubertus J A
Research Department, Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910 Affoltern am Albis, Switzerland.
Children's Research Centre CRC, University Children's Hospital, Zurich, Switzerland.
Pilot Feasibility Stud. 2020 Oct 15;6:156. doi: 10.1186/s40814-020-00694-y. eCollection 2020.
If adults practice several motor tasks together, random practice leads to better transfer and retention compared to blocked practice. Knowledge about this contextual interference (CI) effect could be valuable to improve neurorehabilitation of children. We present the protocol of a randomised controlled pilot study investigating the feasibility of blocked practice vs. random practice of robot-assisted upper limb reaching in children with brain lesions undergoing neurorehabilitation.
Children with affected upper limb function due to congenital or acquired brain lesions undergoing neurorehabilitation will be recruited for a randomised controlled pilot study with a 3-week procedure. In the control week (1), two assessment blocks (robot-assisted reaching tasks, Melbourne assessment 2, subscale fluency), 2 days apart, take place. In the practice week (2), participants are randomly allocated to blocked practice or random practice and perform 480 reaching and backward movements in the horizontal and vertical plane using exergaming with an exoskeleton robot per day during three consecutive days. Assessments are performed before, directly after and 1 day after the practice sessions. In the follow-up week (3), participants perform the assessments 1 week after the final practice session. The primary outcome is the immediate transfer of the Melbourne Assessment 2, subscale fluency. Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions. We will evaluate the feasibility of the inclusion criteria, the recruitment rate, the scheduling procedure, the randomisation procedure, the procedure for the participants, the handling of the robot, the handling of the amount of data, the choice of the outcome measures and the influence of other therapies. Furthermore, we will perform a power calculation using the data to estimate the sample size for the main trial.
The protocol of the pilot study is a first step towards a future main randomised controlled trial. This low risk pilot study might induce some benefits for the participants. However, we need to place its results into perspective, especially concerning the generalisability, as it remains questionable whether improving reaching constrained within a robotic device will ameliorate daily life reaching tasks.
ClinicalTrials.gov Identifier: NCT02443857.
如果成年人同时进行多项运动任务，与集中练习相比，随机练习能带来更好的迁移效果和记忆保持。了解这种情境干扰（CI）效应可能对改善儿童神经康复有重要价值。我们展示了一项随机对照试验性研究的方案，该研究旨在探究在接受神经康复治疗的脑损伤儿童中，集中练习与随机练习机器人辅助上肢伸展的可行性。
因先天性或后天性脑损伤而导致上肢功能受损且正在接受神经康复治疗的儿童将被招募参加一项为期3周的随机对照试验性研究。在对照周（第1周），进行两个评估阶段（机器人辅助伸展任务、墨尔本评估2流畅性子量表），间隔2天。在练习周（第2周），参与者被随机分配到集中练习组或随机练习组，并在连续三天内每天使用外骨骼机器人进行体感游戏，在水平和垂直平面上进行480次伸展和后缩动作。在练习课程前、刚结束后以及结束后1天进行评估。在随访周（第3周），参与者在最后一次练习课程1周后进行评估。主要结果是墨尔本评估2流畅性子量表的即时迁移。次要结果是即时记忆保持、1天和1周延迟迁移与记忆保持以及练习课程期间的习得情况。我们将评估纳入标准的可行性、招募率、日程安排程序、随机化程序、参与者程序、机器人操作、数据量处理、结果测量指标的选择以及其他治疗方法的影响。此外，我们将使用这些数据进行功效计算，以估计主要试验的样本量。
该试验性研究方案是迈向未来主要随机对照试验的第一步。这项低风险试验性研究可能会给参与者带来一些益处。然而，我们需要正确看待其结果，尤其是关于可推广性方面，因为在机器人设备内改善伸展动作是否能改善日常生活中的伸展任务仍值得怀疑。
ClinicalTrials.gov标识符：NCT02443857。
