Gmelig Meyling Christiaan, Verschuren Olaf, Rentinck Ingrid, van der Steen Irene, Engelbert Raoul, Gorter Jan Willem
UMC Utrecht Brain Center Rudolf Magnus, Utrecht, The Netherlands
Department of Pediatric Rehabilitation, De Hoogstraat Rehabilitation, Utrecht, The Netherlands.
BMJ Open. 2025 Jan 20;15(1):e087768. doi: 10.1136/bmjopen-2024-087768.
While principles of neuroplasticity and motor learning emphasise the potential of high dosage of physical rehabilitation in children and adolescents with acquired brain injury (ABI) during the subacute phase, we lack empirical evidence to demonstrate its impact in terms of meaningful outcomes. Clinical research is needed to investigate adequate dosage of physical rehabilitation and its effects on outcomes with reliable and validated outcome measurements. In this study we will investigate the feasibility of a highly intensive physical rehabilitation intervention and outcomes with reliable and valid outcome measurements.
Our study with a prospective case-series design will evaluate (1) The safety and feasibility of a high-intensive physical rehabilitation programme to improve functioning and participation in children and adolescents with ABI, and (2) The feasibility of a core set of clinical outcome measures to assess recovery on relevant International Classification of Functioning, Disability, and Health domains during the subacute phase. We aim to include 10-15 children and adolescents aged 6-20 years with moderate-severe ABI during subacute rehabilitation in a specialised youth department for inpatient rehabilitation in The Netherlands. In the rehabilitation programme, we aim at a highly intensive approach of 3-5 hours physical rehabilitation per day during inpatient rehabilitation. Frequent and systematic assessment (baseline, each consecutive 6 weeks -if applicable- and at discharge) through a core set of outcome measures will provide insights into the degree of recovery of motor and cognitive functioning. We use descriptive and inferential statistics and thematic content analysis for analysis of the data.
The study has been approved by the Medical Ethics Research Committee of the University Medical Hospital, Utrecht (reference number: 23U-0628). We aim to disseminate our findings in peer-reviewed journals and present at national and international conferences.
虽然神经可塑性和运动学习原理强调在亚急性期对获得性脑损伤（ABI）的儿童和青少年进行高剂量物理康复的潜力，但我们缺乏实证证据来证明其在有意义的结果方面的影响。需要进行临床研究，以通过可靠且经过验证的结果测量方法来调查物理康复的适当剂量及其对结果的影响。在本研究中，我们将调查高强度物理康复干预的可行性以及通过可靠且有效的结果测量得出的结果。
我们采用前瞻性病例系列设计的研究将评估：（1）高强度物理康复计划对改善ABI儿童和青少年功能及参与度的安全性和可行性，以及（2）一套核心临床结果测量方法在评估亚急性期相关国际功能、残疾和健康分类领域恢复情况方面的可行性。我们的目标是纳入10 - 15名年龄在6 - 20岁、在荷兰一家专门的青少年住院康复科室进行亚急性康复的中重度ABI儿童和青少年。在康复计划中，我们的目标是在住院康复期间每天进行3 - 5小时的高强度物理康复。通过一套核心结果测量方法进行频繁且系统的评估（基线、每连续6周[如适用]以及出院时），将深入了解运动和认知功能的恢复程度。我们使用描述性和推断性统计以及主题内容分析来分析数据。
该研究已获得乌得勒支大学医学中心医学伦理研究委员会的批准（参考编号：23U - 0628）。我们旨在将研究结果发表在同行评审期刊上，并在国内和国际会议上展示。
