Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, 2-50 Corbett Hall, Edmonton, AB, T6G 2G4, Canada.
Alberta Children's Hospital, Calgary, AB, Canada.
BMC Pediatr. 2022 Aug 10;22(1):480. doi: 10.1186/s12887-022-03525-6.
There is increasing evidence for early, active rehabilitation to enhance motor function following early brain injury. This is clear for interventions targeting the upper extremity, whereas passive treatment approaches for the lower extremity persist. The purpose of this trial is to evaluate the effectiveness of early, intensive rehabilitation targeting the lower extremity and delivered in a parent-therapist partnership model for children with perinatal stroke.
We describe a protocol for a waitlist-control, single-blind, mixed methods effectiveness randomized controlled trial, with an embedded qualitative study using interpretative description. Participants are children with perinatal stroke aged eight months to three years with signs of hemiparesis. Participants will be randomly allocated to an immediate ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) intervention group, or a waitlist-control group, who will receive usual care for six months. The ELEVATE intervention involves one hour of training four days per week for 12 weeks, with a pediatric therapist and a parent or guardian each delivering two sessions per week. The intervention targets the affected lower extremity by progressively challenging the child while standing and walking. The primary outcome measure is the Gross Motor Function Measure-66. Secondary outcomes include the Pediatric Quality of Life Inventory™, Young Children's Participation and Environment Measure, and an instrumented measure of spasticity. A cost-effectiveness analysis and qualitative component will explore benefit to costs ratios and parents' perspectives of early, intensive rehabilitation, and their role as a partner in the rehabilitation, respectively.
This study has the potential to change current rehabilitation for young children with perinatal stroke if the ELEVATE intervention is effective. The parent interviews will provide further insight into benefits and challenges of a partnership model of rehabilitation. The mixed methods design will enable optimization for transfer of this collaborative approach into physical therapy practice.
ClinicalTrials.gov NCT03672864 . Registered 17 September 2018.
越来越多的证据表明，早期积极康复可以促进早期脑损伤后的运动功能。这对于针对上肢的干预措施是明确的，而针对下肢的被动治疗方法则持续存在。本试验的目的是评估针对围产期卒中儿童的下肢早期、强化康复的效果，该康复以家长-治疗师合作模式进行。
我们描述了一项等待对照、单盲、混合方法有效性随机对照试验的方案，其中嵌入了使用解释性描述的定性研究。参与者是患有围产期卒中、年龄在 8 个月至 3 岁之间、有偏瘫迹象的儿童。参与者将被随机分配到立即进行 ELEVATE（通过早期主动治疗来增强下肢活动能力）干预组或等待对照组，后者将在 6 个月内接受常规护理。ELEVATE 干预涉及每周 4 天、每天 1 小时的训练，由儿童治疗师和家长或监护人每周各进行 2 次训练。该干预针对受影响的下肢，通过在站立和行走时逐步挑战儿童来进行。主要结局指标是粗大运动功能测量-66。次要结局指标包括儿童生活质量量表、幼儿参与和环境量表以及痉挛的仪器测量。成本效益分析和定性部分将分别探讨早期强化康复的效益成本比以及家长对早期强化康复及其作为康复伙伴的看法。
如果 ELEVATE 干预有效，这项研究有可能改变目前针对围产期卒中幼儿的康复方法。家长访谈将进一步深入了解合作康复模式的益处和挑战。混合方法设计将能够优化这种协作方法向物理治疗实践的转化。
ClinicalTrials.gov NCT03672864。注册于 2018 年 9 月 17 日。
