Division of Rehabilitation Medicine, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA.
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA.
BMC Pediatr. 2018 Oct 16;18(1):329. doi: 10.1186/s12887-018-1303-8.
Cerebral palsy (CP) is the most common cause of physical disability in children. The best opportunity to maximize lifelong independence is early in motor development when there is the most potential for neuroplastic change, but how best to optimize motor ability during this narrow window remains unknown. We have systematically developed and pilot-tested a novel intervention that incorporates overlapping principles of neurorehabilitation and infant motor learning in a context that promotes upright mobility skill and postural control development. The treatment, called iMOVE therapy, was designed to allow young children with CP to self-initiate motor learning experiences similar to their typically developing peers. This manuscript describes the protocol for a subsequent clinical trial to test the efficacy of iMOVE therapy compared to conventional therapy on gross motor development and other secondary outcomes in young children with CP.
The study is a single-blind randomized controlled trial. Forty-two participants with CP or suspected CP between the ages of 1-3 years will be randomized to receive either the iMOVE or conventional therapy group. Distinguishing characteristics of each group are detailed. Repeated measures of gross motor function will be collected throughout the 12-24 week intervention phase and at three follow-up points over one year post therapy. Secondary outcomes include measures of postural control, physical activity, participation and caregiver satisfaction.
This clinical trial will add to a small, but growing, body of literature on early interventions to optimize the development of motor control in young children with CP. The information learned will inform clinical practice of early treatment strategies and may contribute to improving the trajectory of motor development and reducing lifelong physical disability in individuals with CP.
ClinicalTrials.gov identifier NCT02340026 . Registered January 16, 2015.
脑瘫（CP）是儿童最常见的身体残疾原因。最大限度地提高终身独立性的最佳机会是在运动发展早期，此时神经可塑性变化的潜力最大，但如何在这个狭窄的窗口内最佳地优化运动能力仍然未知。我们已经系统地开发并试点测试了一种新的干预措施，该干预措施将神经康复和婴儿运动学习的重叠原理整合到一个促进直立移动技能和姿势控制发展的环境中。该治疗方法称为 iMOVE 疗法，旨在允许 CP 幼儿自行发起类似于其正常发育同伴的运动学习体验。本文档介绍了一项后续临床试验的方案，该试验旨在测试 iMOVE 疗法与常规疗法相比对 CP 幼儿的粗大运动发育和其他次要结果的疗效。
该研究是一项单盲随机对照试验。将 42 名年龄在 1-3 岁之间的 CP 或疑似 CP 患儿随机分为接受 iMOVE 或常规治疗组。每组的区别特征详细说明。在 12-24 周的干预阶段和治疗后一年的三个随访点，将对粗大运动功能进行重复测量。次要结果包括姿势控制、身体活动、参与和照顾者满意度的测量。
本临床试验将补充有关优化 CP 幼儿运动控制发展的早期干预的少量但不断增长的文献。所获得的信息将为早期治疗策略的临床实践提供信息，并可能有助于改善运动发展轨迹并减少 CP 个体的终身身体残疾。
ClinicalTrials.gov 标识符 NCT02340026。于 2015 年 1 月 16 日注册。
