UCLouvain, Institute of Neuroscience, COSY Pole, MSL-IN Lab, Brussels, Belgium.
Motor Sciences department, FfH Lab, CeREF Santé, HELHa, Rue Trieu Kaisin, 136, 6061, Montignies-Sur-Sambre, Belgium.
J Neuroeng Rehabil. 2023 Jul 29;20(1):98. doi: 10.1186/s12984-023-01218-4.
The implementation of virtual devices can facilitate the role of therapists (e.g., patient motivation, intensity of practice) to improve the effectiveness of treatment for children with cerebral palsy. Among existing therapeutic devices, none has been specifically designed to promote the application of principles underlying evidence-based motor skill learning interventions. Consequently, evidence is lacking regarding the effectiveness of virtual-based sessions in motor function rehabilitation with respect to promoting the transfer of motor improvements into daily life activities. We tested the effectiveness of implementing a recently developed virtual device (REAtouch), specifically designed to enable the application of therapeutic motor skill learning principles, during a Hand Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) intervention.
Forty children with unilateral cerebral palsy (5-18 years; MACS I-III; GMFCS I-II) were randomly assigned to a control group or a "REAtouch" experimental group for a 90-h HABIT-ILE day-camp intervention (two weeks). Children in the REAtouch group spent nearly half of their one-on-one therapeutic time using the REAtouch. Participants underwent three testing sessions: the week before (T1), after intervention (T2), and at three months follow-up (T3). The primary outcome was the Assisting Hand Assessment (T3-T1; blinded). Secondary outcomes measured uni-bimanual hand function, stereognosis, gait endurance, daily life abilities, and functional goals. Accelerometers and a manual report of daily activities served to document therapeutic dosage and treatment characteristics. We used one-way RMANOVA to compare the efficacies of the two interventions, and non-inferiority analyses to contrast changes in the "REAtouch" group versus the "HABIT-ILE" control group.
We found significant improvements in both groups for most of the outcome measures (p < 0.05). There was significant non-inferiority of changes in the REAtouch group for upper extremities motor function, functional goals attainment, and abilities in daily life activities (p < 0.05).
Use of the REAtouch device during HABIT-ILE showed non-inferior efficacy compared to the conventional evidence-based HABIT-ILE intervention in children with unilateral cerebral palsy. This study demonstrates the feasibility of using this virtual device in a high dosage camp model, and establishes the possibility of applying the therapeutic principles of motor skill learning during specifically designed virtual-based sessions.
Trial registration number: NCT03930836-Registration date on the International Clinical Trials Registry Platform (ICTRP): June 21th, 2018; Registration date on NIH Clinical Trials Registry: April 29th, 2019. First patient enrollment: July 3rd, 2018.
虚拟设备的实施可以促进治疗师的角色（例如，患者动机，练习强度），从而提高脑瘫儿童治疗的效果。在现有的治疗设备中，没有专门用于促进基于证据的运动技能学习干预原则应用的设备。因此，缺乏关于虚拟基于会话在运动功能康复方面促进运动改善转移到日常生活活动中的有效性的证据。我们测试了在 Hand Arm Bimanual Intensive Therapy Including Lower Extremities（HABIT-ILE）干预期间实施最近开发的虚拟设备（REAtouch）的有效性，该设备专门设计用于应用治疗运动技能学习原则。
40 名单侧脑瘫儿童（5-18 岁；MACS I-III；GMFCS I-II）被随机分配到对照组或“REAtouch”实验组进行 90 小时的 HABIT-ILE 日间营地干预（两周）。REAtouch 组的儿童在一对一的治疗时间中几乎有一半时间使用 REAtouch。参与者接受了三次测试：干预前一周（T1），干预后（T2）和三个月后随访（T3）。主要结局是辅助手评估（T3-T1；盲法）。次要结局衡量单手手功能，触觉识别，步态耐力，日常生活能力和功能目标。加速度计和日常活动的手动报告用于记录治疗剂量和治疗特征。我们使用单向 RMANOVA 比较两种干预措施的疗效，并使用非劣效性分析比较“REAtouch”组与“HABIT-ILE”对照组的变化。
我们发现两组大多数结局测量值均有显著改善（p<0.05）。REAtouch 组上肢运动功能，功能目标实现以及日常生活活动能力的变化具有显著的非劣效性（p<0.05）。
在 HABIT-ILE 期间使用 REAtouch 设备与传统的基于证据的 HABIT-ILE 干预相比，在单侧脑瘫儿童中具有非劣效的疗效。这项研究证明了在高剂量营地模型中使用这种虚拟设备的可行性，并确定了在专门设计的虚拟会话中应用运动技能学习治疗原则的可能性。
试验注册号：NCT03930836-在国际临床试验注册平台（ICTRP）上的注册日期：2018 年 6 月 21 日；在美国国立卫生研究院临床试验注册处的注册日期：2019 年 4 月 29 日。首例患者入组：2018 年 7 月 3 日。
