基于临床调研的下肢外骨骼康复机器人优化设计与落地路径研究

      Optimized Design and Translation Pathways for Lower-Limb Rehabilitation Exoskeleton Robots Based on Clinical Investigation

      • 摘要: 现有下肢外骨骼康复机器人研发偏重实验室工程性能优化,技术方案与临床实际需求脱节,立足一线场景的需求导向型设计研究不足。该文采用探索性横断面调查设计,以浙江杭州地区三级综合医院及专科康复医院中具备外骨骼临床操作经验的63名一线康复从业人员为样本,融合定量问卷调查与半结构化质性访谈,从设备应用现状、临床实操痛点、功能升级需求、运维采购偏好、产业推广制约等多维度开展系统分析。结果显示:穿戴调试烦琐耗时(77.8%)、设备自重过大(42.9%)、预设步态与人体自然运动适配差(42.9%)为三大核心应用短板;实时生物力学动态反馈(81.0%)、医院信息系统(hospital information systems,HIS)互联互通(58.7%)、多模态智能交互(54.0%)为最迫切的功能升级需求;医保报销覆盖有限(87.3%)、高质量临床循证数据匮乏(57.1%)为规模化落地的主要制约因素。据此,该文从核心痛点技术破解、场景化模块化设计、产业化路径探索、全周期主动运维四个维度提出系统对策,构建“通用硬件平台+场景化功能模块+全周期数智化服务 ”三位一体研发与落地框架。研究结论可为国产下肢外骨骼康复机器人的临床适配优化与产业化落地提供数据支撑与决策参考。

         

        Abstract: Current development of lower-limb rehabilitation exoskeleton robots has so far emphasized engineering performance optimization in the laboratory, while technical solutions remain disconnected from real clinical needs; needs-oriented design research grounded in frontline clinical scenarios remains scarce. This study adopted an exploratory cross-sectional design and recruited 63 frontline rehabilitation practitioners with clinical experience in exoskeleton operation from tertiary general hospitals and specialized rehabilitation hospitals in Hangzhou, Zhejiang. Combining quantitative questionnaires with semi-structured qualitative interviews, it systematically examined five dimensions: current device application, clinical pain points, functional upgrade needs, operation and maintenance and procurement preferences, and barriers to industrial promotion. The results revealed three core application shortcomings—time-consuming donning and adjustment (77.8%), excessive device weight (42.9%), and poor matching between preset gait patterns and natural human movement (42.9%); the most urgent functional upgrades were real-time dynamic biomechanical feedback (81.0%), interoperability with hospital information systems (HIS) (58.7%), and multimodal intelligent interaction (54.0%); and the major obstacles to scaled deployment were limited medical insurance reimbursement coverage (87.3%) and insufficient high-quality clinical evidence (57.1%). Accordingly, countermeasures were proposed in four dimensions—technological solutions for core pain points, scenario-based modular design, industrial translation pathways, and full-lifecycle proactive operation and maintenance—and a three-in-one framework for development and translation was established, namely "a universal hardware platform, scenario-specific functional modules, and full-lifecycle digital-intelligent services". The findings can provide data support and decision-making references for optimizing clinical adaptability and promoting the industrial translation of domestically manufactured lower-limb rehabilitation exoskeletons robots.

         

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