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This protocol aims to develop an innovative smart walker for clinical use, guided by feature-requirement identification, user-centred co-design with older patients and clinicians, and real-time pilot testing in German clinics. 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Development of a smart walker for clinical settings: a protocol of an exploratory mixedmethods study. BMJ Open 2025;15:e105342 . doi:10 . 1136/ bmjopen-2025-105342  \n► Prepublication history for this paper is available online. To view these files, please visit the journal online ([https://doi](https://doi). org/10 . 1136/bmjopen-2025- 105342) .  \nReceived 19 May 2025  \nAccepted 11 December 2025  \n© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.  \n1Munich Campus for Health and Engineering, Munich University of Applied Sciences, Munich, Germany  \n2Department of Orthopaedic and Trauma Surgery, Martin-LutherUniversität Halle-Wittenberg Medizinische Fakultät, Halle (Saale), Germany  \n3Institute for Rehabilitation Medicine, Martin-LutherUniversität Halle-Wittenberg, Halle (Saale), Germany  \nCorrespondence to  \nProfessor Nicole Strutz; [nicole.strutz@hm.edu](nicole.strutz@hm.edu)  \nABSTRACT  \nIntroduction Mobilisation and mobility in clinical settings are essential to the recovery process after surgery and trauma-related hospital admission. In addition to personal support from physiotherapists and nursing staff, aids such as walkers are applied. Walkers equipped with smart features have the potential to benefit geriatric patients by facilitating routine clinical workflows and, where appropriate, by providing health professionals with information on gait patterns and vital parameters. The overarching goal of this project is to develop an innovative smart walker for clinical use, guided by three objectives: (a) Identify the feature requirements of the smart walker from the perspectives of patients and health professionals,(b) Co-design the smart walker using a user-centred approach involving older patients, health professionals and clinical engineers and (c) Pilot-test the smart walker in real time with older patients admitted to German clinics.  \nMethods and analysis We will employ a three-phased exploratory sequential mixed-methods approach in this project. Phase I explores potentially useful characteristics of a smart walker via a scoping literature review (part 1 of phase I) and a qualitative interview and observational study, including questionnaires on sociodemographic data and technology readiness, involving four to six patients and four to eight nurses and physiotherapists (part 2 of phase I) . Phase II focuses on developing and validating a smart walker through a user experience design, with at least three iterative test cycles involving a minimum of three asymptomatic participants and three to seven potential users in each cycle. Phase III comprises a pilot study conducted at a University Hospital in Germany involving at least twelve patients. Data integration takes a data-building approach, combining qualitative and quantitative results in the final analysis to generate a comprehensive understanding and to create and refine insights into the feature needs and use of a smart walker by patients.  \nEthics and dissemination The study was approved by the Ethics Committee of University Medicine Halle, Germany (Approval No. 2025-032; date of approval:  \n03/04/2025) . Study results will be disseminated through peer-reviewed journals and conferences.  \nPROSPERO registration number The study protocol was registered at the Open Science Framework Platform (OSF, register number: 10.17605/OSF.IO/CTPF4) .  \nSTRENGTHS AND LIMITATIONS OF THIS STUDY   \n⇒ Users will be actively involved in the development process, contributing their experiences, needs and preferences regarding a smart walker. Due to their iterative participation at every stage of the study, we aim for a","cbCainUtXLbpzlAx","https://ap.wps.com/l/cbCainUtXLbpzlAx","pdf",365774,"English","# Abstract\n# Introduction\n## Clinical mobility and recovery needs\n## Early mobilisation and care continuum impacts\n# Methods and analysis\n## Phase I: scoping review, interviews, and observational study\n## Phase II: iterative user experience design and validation\n## Phase III: hospital pilot study and data integration\n# Ethics and dissemination\n# Strengths and limitations","[{\"question\":\"What is the primary goal of developing the smart walker in this protocol?\",\"answer\":\"To develop an innovative smart walker for clinical use, supported by three objectives: defining feature requirements, co-designing it in a user-centred way, and pilot-testing it in real time with older patients in German clinics.\"},{\"question\":\"How does the study combine qualitative and quantitative methods?\",\"answer\":\"It uses a three-phased exploratory sequential mixed-methods approach and applies data integration via a data-building approach, combining qualitative and quantitative results in the final analysis.\"},{\"question\":\"What happens in each phase of the mixed-methods study?\",\"answer\":\"Phase I explores characteristics using a scoping literature review plus qualitative interviews and observational work with questionnaires. Phase II develops and validates the smart walker through iterative user experience test cycles. Phase III conducts a hospital pilot study with at least twelve patients.\"}]","Development of a smart walker for clinical settings - a protocol of an exploratory mixed-methods study | PDF",1790671296]