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 Hand search was done additionally and contact to experts used to retrieve unpublished manuscripts.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：帕多万法神经功能重组®（PADOVAN-METHOD NEUROFUNCTIONAL REORGANISATION®）是一种颇具应用前景的言语治疗手段，用于治疗创伤性或先天性病因的神经发育障碍。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（systematic review）开展系统性评估。本报告旨在为该疗法的临床应用提供循证依据。

方法与研究方案：本研究遵循系统评价和Meta分析优先报告条目（PRISMA）、考克兰协作网手册（Cochrane Collaboration Handbook）、MECIR及推荐分级的评估、制定与评价（GRADE）指南。检索范围涵盖通用数据库（考克兰图书馆、PubMed、德国医学科学专业学会联合会[AWMF]、Anthromedics等）及包括灰色文献（grey literature）在内的其余38个数据库，同时辅以手工检索，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、对比该疗法与无干预、现有标准替代疗法或安慰剂干预的疗效相关试验，未对研究设计施加限制。由研究人员独立提取与干预结局及研究方法相关的数据并开展分析。偏倚风险（Risk of Bias）评估方面，针对非随机对照试验（non-RCTs）采用非随机研究偏倚风险评估工具（ROBINS-I）进行评价；针对病例系列或病例报告，核查其是否遵循病例报告指南（CARE-Guidelines）；所有研究均需符合赫尔辛基宣言（Declaration of Helsinki）的相关要求。研究结果将依据GRADE标准，通过证据概要表（evidence profiles）及结果总结表（summary of findings tables）进行呈现。

研究结果：在经资格筛选的98条文献记录中，最终纳入4项研究及14篇病例报告，共涉及196名受试者。报告的干预时长介于2天至2年之间。受试者所患神经发育障碍的主要病症包括小头畸形（Microcephalia）、唐氏综合征（down-syndrome）、未明确分类的神经系统疾病及肌功能障碍（myo-functional disorders）。纳入研究的操作定义仅存在间接重叠，因此本研究结论存在一定局限性。

研究结论：帕多万法®是一种整体治疗方案，其宣称可适用于广泛的病症谱，这使得疗效验证颇具难度。临床医师可考虑由经过培训的治疗师按照帕多万法®开展治疗（弱推荐），该疗法或可缓解上述病症的相关症状并改善患者病情。因此，亟需制定并验证标准化治疗方案，并开展进一步的相关研究。

PROSPERO注册编号：CRD42020156124

关键词：神经康复、言语语言障碍康复、神经发育障碍、系统评价