Supplementary Material for: Recommendation of Neurorehabilitation according to the Padovan-Method Neurofunctional Reorganisation® for Treating Neurodevelopmental Disorders: A Systematic Review

Objective: The PADOVAN-METHOD NEUROFUNCTIONAL REORGANI¬SATION® is a promising approach in speech therapy treating neuro¬developmental disorders with traumatic or congenital origin. Its use is based on a long-time experience of certified therapists. However, its efficacy and safety has not been assessed in a systematic review. This report aims to gain evidence for the use of the therapy method. Methods and analysis: Guidelines of PRISMA, the Cochrane Collaboration Handbook, MECIR and GRADE were followed. General databases (Cochrane Library, PubMed, AWMF, Anthromedics, etc.) and further 38 databases including grey literature were searched. Hand search was done additionally and contact to experts used to retrieve unpublished manuscripts. All trials investigating the effect of the method in comparison to either no intervention, alternative as state of the art or placebo intervention in English, Portuguese and German language were included. No restriction regarding study design was applied. Data related to the intervention outcome and the study method was extracted and analysed idependently. Risk of Bias was assessed using ROBINS-I for non-RCTs, adherence to CARE-Guidelines was analysed for case series or reports and keeping the Declaration of Helsinki was checked for all items. Results are presented both in evidence profiles and summary of findings tables according to GRADE. Results: Amongst 98 records assessed for eligibility, four studies and 14 case reports were identified with a total of n = 196 participants. Duration of reported interventions was between two days and two years. Microcephalia, down-syndrome, unspecified neurological disorders and myo-functional disorders were main conditions of the patients with neurodevelopmental disorders. Only indirect overlapping of operationalised criteria was found. Conclusions are therefore limited. Conclusion: The Padovan-Method® is a holistic therapy approach claiming its feasibility to a large group of disorders making a proof of efficacy difficult. An application of therapy according to the Padovan-Method® by trained therapists might be considered by clinicians (weak recommendation) and a contribution to a relief of symptoms or improvements of condition of named conditions might be gained. Therefore, development and validation of therapy protocols and further investigation are required. PROSPERO Registration: CRD42020156124. Keywords: neurological rehabilitation, neurodevelopmental disorders, rehabilitation of speech and language disorders, systematic review研究目的：帕多万疗法神经功能重组法（PADOVAN-METHOD NEUROFUNCTIONAL REORGANISATION®）是治疗创伤性或先天性神经发育障碍的一种颇具前景的言语治疗方案。该疗法的应用基于认证治疗师的长期临床经验，但其有效性与安全性尚未通过系统评价进行评估。本报告旨在为该疗法的临床应用提供循证依据。 方法与研究设计：本研究遵循PRISMA报告规范、考克兰协作网手册、MECIR指南以及GRADE推荐分级系统。检索范围涵盖常规数据库（考克兰图书馆、PubMed、德国医学科学专业协会联合会[AWMF]、Anthromedics数据库等）及包括灰色文献在内的其余38个数据库，同时开展手工检索并联系专家以获取未发表手稿。纳入所有以英语、葡萄牙语及德语发表的、评估该疗法与无干预、现有标准疗法或安慰剂干预对照效果的试验，不限制研究设计类型。由研究者独立提取并分析干预结局与研究方法相关数据。对于非随机对照试验，采用ROBINS-I工具评估偏倚风险；对于病例系列或病例报告，分析其对CARE指南的依从性；所有研究均核查其是否符合《赫尔辛基宣言》的各项要求。研究结果将依据GRADE系统以证据概况表与结果总结表的形式呈现。 研究结果：经资格审查的98条记录中，最终纳入4项研究与14篇病例报告，共计196名受试者。报告的干预时长介于2天至2年之间。纳入的神经发育障碍患者主要病症包括小头畸形、唐氏综合征、未明确分类的神经系统疾病以及肌功能障碍。仅发现各操作化标准存在间接重叠，因此研究结论存在局限性。 研究结论：帕多万疗法（Padovan-Method®）是一种整体治疗方案，其宣称可适用于多种病症，但这使得其疗效验证颇具难度。临床医师可考虑由经过培训的治疗师实施该疗法（弱推荐），该疗法或可缓解上述病症的症状并改善患者病情。因此，亟需制订并验证标准化治疗方案，并开展进一步研究。 PROSPERO注册编号：CRD42020156124。 关键词：神经康复；神经发育障碍；言语语言康复；系统评价