{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T15:11:07Z","timestamp":1789139467254,"version":"build-2803163510"},"reference-count":47,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T00:00:00Z","timestamp":1740355200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Physiotherapy in the clinic is highly recommended for improving gait, balance, and fall risk in people with Parkinson\u2019s disease. In addition, technology may help boost unsupervised exercise hours at home. Strolll is an augmented-reality (AR) neurorehabilitation platform for delivering gait-and-balance exercises onto AR glasses that can be performed under direct supervision of the therapist in the clinic, but also independently at home. Strolll AR also has the option to integrate AR cueing in gait-and-balance exercises to assist people with more severe mobility impairments in performing the exercises. The objective of this pragmatic randomized controlled trial (RCT) on Strolll AR is to examine its clinical feasibility and effectiveness for improving indicators of gait, balance, and falls risk. A secondary objective is to evaluate procedures for tailoring assistive AR cues.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 100 people with Parkinson\u2019s disease (Hoehn and Yahr stages 1\u20133) with gait and\/or balance impairments will participate in this study. This study is a pragmatic RCT in which all participants follow the same procedure. After a baseline assessment (T0), participants will start with a 6-week usual care control period, followed by a midterm assessment (T1). Subsequently, participants will undergo 2 weeks of in-clinic familiarization with Strolll AR. Then, participants will start with the 6-week Strolll AR intervention at home, followed by a final in-clinic assessment (T2). The primary study parameters are feasibility (i.e., safety, adherence, performance, and user experience) and effectiveness for improving indicators of gait, balance, and falls risk. For the statistical analyses on effectiveness, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple (<jats:italic>n<\/jats:italic>\u202f=\u202f20) randomizations. Recruitment started in May 2024 and the last T2 assessment is expected in February 2025.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The design of this particular pragmatic RCT will demonstrate feasibility and effectiveness in a real-world setting and in a representative population. Strolll AR may facilitate the transition from supervised care in the clinic to independent care at home, providing a platform for delivering individualized treatment, assisted with AR cues when deemed beneficial, for improving gait, balance, and falls risk in people with Parkinson\u2019s disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p><jats:uri>https:\/\/clinicaltrials.gov\/<\/jats:uri>, identifier NCT06590987<\/jats:p><\/jats:sec>","DOI":"10.3389\/fneur.2025.1512409","type":"journal-article","created":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T05:10:41Z","timestamp":1740373841000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["Cueing-assisted gamified augmented-reality gait-and-balance rehabilitation at home for people with Parkinson\u2019s disease: protocol of a pragmatic randomized controlled trial implemented in the clinical pathway"],"prefix":"10.3389","volume":"16","author":[{"given":"Daphne J.","family":"Geerse","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva M.","family":"Hoogendoorn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter F.","family":"van Doorn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jara S.","family":"van Bergem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annejet T.","family":"van Dam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lotte E. S.","family":"Hardeman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melvyn","family":"Roerdink","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,2,24]]},"reference":[{"key":"ref1","volume-title":"European physiotherapy guideline for Parkinson\u2019s disease","author":"Keus","year":"2014"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"930","DOI":"10.1080\/00207454.2016.1275617","article-title":"Physical therapy and occupational therapy in Parkinson's disease","volume":"127","author":"Radder","year":"2017","journal-title":"Int J Neurosci"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1339","DOI":"10.2522\/ptj.20100236","article-title":"Profile of functional limitations and task performance among people with early- and middle-stage Parkinson disease","volume":"91","author":"Schenkman","year":"2011","journal-title":"Phys Ther"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1007\/s13760-023-02428-2","article-title":"Prognostic factors for falls in Parkinson\u2019s disease: a systematic review","volume":"124","author":"Murueta-Goyena","year":"2023","journal-title":"Acta Neurol Belg"},{"key":"ref5","volume-title":"Improving the clinical effectiveness of physiotherapy in Parkinson's disease","author":"Meek","year":"2011"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"2214","DOI":"10.1007\/s00415-011-6097-7","article-title":"Physical inactivity in Parkinson's disease","volume":"258","author":"van Nimwegen","year":"2011","journal-title":"J Neurol"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/ptj\/pzab302","article-title":"Physical therapist Management of Parkinson Disease: a clinical practice guideline from the American Physical Therapy Association","volume":"102","author":"Osborne","year":"2022","journal-title":"Phys Ther"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"1451","DOI":"10.1136\/bjsports-2020-102955","article-title":"World Health Organization 2020 guidelines on physical activity and sedentary behaviour","volume":"54","author":"Bull","year":"2020","journal-title":"Br J Sports Med"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"e859","DOI":"10.1212\/WNL.0000000000013218","article-title":"Long-term effect of regular physical activity and exercise habits in patients with early Parkinson disease","volume":"98","author":"Tsukita","year":"2022","journal-title":"Neurology"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"189","DOI":"10.1016\/j.jphys.2019.08.003","article-title":"Home-based prescribed exercise improves balance-related activities in people with Parkinson's disease and has benefits similar to centre-based exercise: a systematic review","volume":"65","author":"Flynn","year":"2019","journal-title":"J Physiother"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"2751","DOI":"10.3390\/healthcare11202751","article-title":"Rehabilitation Technologies for Chronic Conditions: will we sink or swim?","volume":"11","author":"LaMarca","year":"2023","journal-title":"Healthcare"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"2995","DOI":"10.1007\/s10072-021-05855-2","article-title":"Effect of home-based virtual reality training and Telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis","volume":"43","author":"Truijen","year":"2022","journal-title":"Neurol Sci"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"734","DOI":"10.1016\/j.jfma.2015.07.012","article-title":"Home-based virtual reality balance training and conventional balance training in Parkinson's disease: a randomized controlled trial","volume":"115","author":"Yang","year":"2016","journal-title":"J Formos Med Assoc"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"933","DOI":"10.1093\/ptj\/pzaa042","article-title":"Effect of virtual reality on balance in individuals with Parkinson disease: a systematic review and meta-analysis of randomized controlled trials","volume":"100","author":"Chen","year":"2020","journal-title":"Phys Ther"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"1373740","DOI":"10.3389\/fneur.2024.1373740","article-title":"Remotely prescribed, monitored, and tailored home-based gait-and-balance exergaming using augmented reality glasses: a clinical feasibility study in people with Parkinson's disease","volume":"15","author":"Hardeman","year":"2024","journal-title":"Front Neurol"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"695","DOI":"10.1191\/0269215505cr906oa","article-title":"Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review","volume":"19","author":"Lim","year":"2005","journal-title":"Clin Rehabil"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"S475","DOI":"10.1002\/mds.21978","article-title":"Cueing for freezing of gait in patients with Parkinson's disease: a rehabilitation perspective","volume":"23","author":"Nieuwboer","year":"2008","journal-title":"Mov Disord"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/j.clineuro.2014.06.026","article-title":"Effects of external cues on gait parameters of Parkinson's disease patients: a systematic review","volume":"124","author":"Rocha","year":"2014","journal-title":"Clin Neurol Neurosurg"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"628388","DOI":"10.3389\/fneur.2021.628388","article-title":"Holocue: a wearable holographic cueing application for alleviating freezing of gait in Parkinson's disease","volume":"12","author":"Geerse","year":"2022","journal-title":"Front Neurol"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"1379243","DOI":"10.3389\/fneur.2024.1379243","article-title":"Gait-modifying effects of augmented-reality cueing in people with Parkinson's disease","volume":"15","author":"Hoogendoorn","year":"2024","journal-title":"Front Neurol"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"105189","DOI":"10.1016\/j.neubiorev.2023.105189","article-title":"One Cue does not fit all: a systematic review with Meta-analysis of the effectiveness of cueing on freezing of gait in Parkinson's disease","volume":"150","author":"Cosentino","year":"2023","journal-title":"Neurosci Biobehav Rev"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"e2253","DOI":"10.1212\/WNL.0000000000201159","article-title":"Evaluation of compensation strategies for gait impairment in patients with Parkinson disease","volume":"99","author":"Tosserams","year":"2022","journal-title":"Neurology"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1097\/NRL.0b013e31826a99d1","article-title":"Cueing for freezing of gait: a need for 3-dimensional cues?","volume":"18","author":"Snijders","year":"2012","journal-title":"Neurologist"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"80","DOI":"10.1186\/s13063-024-07935-y","article-title":"Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: Prime-9\u2014pragmatic research and innovation through multinational experimentation","volume":"25","author":"Omerovic","year":"2024","journal-title":"Trials"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1007\/s10742-018-0192-5","article-title":"Pragmatic randomized clinical trials: best practices and statistical guidance","volume":"19","author":"Gamerman","year":"2018","journal-title":"Health Serv Outcomes Res Methodol"},{"key":"ref26","volume-title":"Computer Software","year":"2024"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"695","DOI":"10.1111\/j.1532-5415.2005.53221.x","article-title":"The Montreal cognitive assessment, Moca: a brief screening tool for mild cognitive impairment","volume":"53","author":"Nasreddine","year":"2005","journal-title":"J Am Geriatr Soc"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"2129","DOI":"10.1002\/mds.22340","article-title":"Movement Disorder Society-sponsored revision of the unified Parkinson's disease rating scale (MDS-UPDRS): scale presentation and Clinimetric testing results","volume":"23","author":"Goetz","year":"2008","journal-title":"Mov Disord"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1016\/j.gaitpost.2009.07.108","article-title":"Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers","volume":"30","author":"Nieuwboer","year":"2009","journal-title":"Gait Posture"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/0895-4356(93)90053-4","article-title":"The physical activity scale for the elderly (PASE): development and evaluation","volume":"46","author":"Washburn","year":"1993","journal-title":"J Clin Epidemiol"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1111\/j.1532-5415.1991.tb01616.x","article-title":"The timed \"up & go\": a test of basic functional mobility for frail elderly persons","volume":"39","author":"Podsiadlo","year":"1991","journal-title":"J Am Geriatr Soc"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"1431","DOI":"10.1016\/j.apmr.2011.04.008","article-title":"Five times sit-to-stand test performance in Parkinson's disease","volume":"92","author":"Duncan","year":"2011","journal-title":"Arch Phys Med Rehabil"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"6","DOI":"10.3109\/03790799009166594","article-title":"Mobility after stroke: reliability of measures of impairment and disability","volume":"12","author":"Collen","year":"1990","journal-title":"Int Disabil Stud"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"323","DOI":"10.2340\/16501977-0537","article-title":"Using psychometric techniques to improve the balance evaluation systems test: the Mini-Bestest","volume":"42","author":"Franchignoni","year":"2010","journal-title":"J Rehabil Med"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"614","DOI":"10.1093\/ageing\/afi196","article-title":"Development and initial validation of the falls efficacy scale-international (Fes-I)","volume":"34","author":"Yardley","year":"2005","journal-title":"Age Ageing"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"1987","DOI":"10.1377\/hlthaff.2017.0832","article-title":"Parkinsonnet: a low-cost health care innovation with a systems approach from the Netherlands","volume":"36","author":"Bloem","year":"2017","journal-title":"Health Aff"},{"key":"ref37","doi-asserted-by":"crossref","DOI":"10.1007\/978-3-540-89350-9_6","article-title":"Construction and evaluation of a user experience questionnaire","volume-title":"HCI and usability for education and work","author":"Laugwitz","year":"2008"},{"key":"ref38","doi-asserted-by":"publisher","first-page":"425","DOI":"10.2307\/30036540","article-title":"User acceptance of information technology: toward a unified view","volume":"27","author":"Venkatesh","year":"2003","journal-title":"MIS Q"},{"key":"ref39","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1186\/1471-2288-11-112","article-title":"Pre-validation methods for developing a patient reported outcome instrument","volume":"11","author":"Prior","year":"2011","journal-title":"BMC Med Res Methodol"},{"key":"ref40","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1016\/j.parkreldis.2004.06.003","article-title":"Measuring gait and gait-related activities in Parkinson's patients own home environment: a reliability, responsiveness and feasibility study","volume":"11","author":"Lim","year":"2005","journal-title":"Parkinsonism Relat Disord"},{"key":"ref41","doi-asserted-by":"publisher","first-page":"114","DOI":"10.2522\/ptj.20090126","article-title":"Minimal detectable change of the timed \u201cup & go\u201d test and the dynamic gait index in people with Parkinson disease","volume":"91","author":"Huang","year":"2011","journal-title":"Phys Ther"},{"key":"ref42","volume-title":"JASP (version 0.19.0)","year":"2024"},{"key":"ref43","doi-asserted-by":"crossref","DOI":"10.4135\/9781412983419","volume-title":"Anova: repeated measures","author":"Girden","year":"1992"},{"key":"ref44","volume-title":"Parkinson\u2019s Excellence Network: UK Parkinson's audit - summary report","author":"Wathes","year":"2022"},{"key":"ref45","volume-title":"Missies Gezondheid & Zorg 2024-2027","year":"2023"},{"key":"ref46","volume-title":"Toekomstbeelden 2030","year":"2022"},{"key":"ref47","first-page":"1","volume-title":"Improving patient care: the implementation of change in health care","author":"Grol","year":"2020"}],"container-title":["Frontiers in Neurology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2025.1512409\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T05:10:48Z","timestamp":1740373848000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2025.1512409\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,24]]},"references-count":47,"alternative-id":["10.3389\/fneur.2025.1512409"],"URL":"https:\/\/doi.org\/10.3389\/fneur.2025.1512409","relation":{},"ISSN":["1664-2295"],"issn-type":[{"value":"1664-2295","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,24]]},"article-number":"1512409"}}