{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T13:50:13Z","timestamp":1776952213426,"version":"3.51.4"},"reference-count":29,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2021,7,18]],"date-time":"2021-07-18T00:00:00Z","timestamp":1626566400000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"AbbVie\n                                    S.L.U.","award":["SA-002841"],"award-info":[{"award-number":["SA-002841"]}]},{"DOI":"10.13039\/501100004587","name":"Instituto\n                                    de Salud Carlos III","doi-asserted-by":"publisher","award":["DTS17\/00195"],"award-info":[{"award-number":["DTS17\/00195"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec>\n                        <jats:title>Introduction<\/jats:title>\n                        <jats:p>In recent years, multiple studies have aimed to develop and validate\n                            portable technological devices capable of monitoring the motor\n                            complications of Parkinson\u2019s disease patients (Parkinson\u2019s Holter). The\n                            effectiveness of these monitoring devices for improving clinical control\n                            is not known.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Methods and analysis<\/jats:title>\n                        <jats:p>This is a single-blind, cluster-randomised controlled clinical\n                            trial. Neurologists from Spanish health centres will be randomly\n                            assigned to one of three study arms (1:1:1): (a) therapeutic adjustment\n                            using information from a Parkinson\u2019s Holter that will be worn by their\n                            patients for 7 days, (b) therapeutic adjustment using information from a\n                            diary of motor fluctuations that will be completed by their patients for\n                            7 days and (c) therapeutic adjustment using clinical information\n                            collected during consultation. It is expected that 162 consecutive\n                            patients will be included over a period of 6 months.<\/jats:p>\n                        <jats:p>The primary outcome is the efficiency of the Parkinson\u2019s Holter\n                            compared with traditional clinical practice in terms of Off time\n                            reduction with respect to the baseline (recorded through a diary of\n                            motor fluctuations, which will be completed by all patients). As\n                            secondary outcomes, changes in variables related to other motor\n                            complications (dyskinesia and freezing of gait), quality of life,\n                            autonomy in activities of daily living, adherence to the monitoring\n                            system and number of doctor\u2013patient contacts will be analysed. The\n                            noninferiority of the Parkinson\u2019s Holter against the diary of motor\n                            fluctuations in terms of Off time reduction will be studied as the\n                            exploratory objective.<\/jats:p>\n                        <jats:p>Ethics and dissemination approval for this study has been obtained\n                            from the Hospital Universitari de Bellvitge Ethics Committee. The\n                            results of this study will inform the practical utility of the objective\n                            information provided by a Parkinson\u2019s Holter and, therefore, the\n                            convenience of adopting this technology in clinical practice and in\n                            future clinical trials. We expect public dissemination of the results in\n                            2022.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Trial registration<\/jats:title>\n                        <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04176302\">NCT04176302<\/jats:ext-link>;<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/show\/NCT04176302\">https:\/\/clinicaltrials.gov\/show\/NCT04176302<\/jats:ext-link><\/jats:p>\n                    <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045272","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T15:10:51Z","timestamp":1667574651000},"page":"e045272","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Multicentre, randomised, single-blind, parallel group trial to compare\n                        the effectiveness of a Holter for Parkinson\u2019s symptoms against other\n                        clinical monitoring methods: study protocol"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04176302","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9678-2654","authenticated-orcid":false,"given":"Alejandro","family":"Rodr\u00edguez-Molinero","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Hern\u00e1ndez-Vara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Mi\u00f1arro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"P\u00e9rez-L\u00f3pez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00c0ngels","family":"Bayes-Rusi\u00f1ol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Carlos","family":"Mart\u00ednez-Castrillo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David A","family":"P\u00e9rez-Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,7,19]]},"reference":[{"key":"2022110304312219000_11.7.e045272.1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252807.38124.a3"},{"key":"2022110304312219000_11.7.e045272.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61393-3"},{"key":"2022110304312219000_11.7.e045272.3","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1097\/WNF.0b013e31823dec73","article-title":"What factors influence motor complications in Parkinson disease?: a 10-year prospective study","volume":"35","author":"Garc\u00eda-Ruiz","year":"2012","journal-title":"Clin Neuropharmacol"},{"key":"2022110304312219000_11.7.e045272.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa033447"},{"key":"2022110304312219000_11.7.e045272.5","doi-asserted-by":"publisher","DOI":"10.1002\/mds.1090"},{"key":"2022110304312219000_11.7.e045272.6","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2003.022780"},{"key":"2022110304312219000_11.7.e045272.7","doi-asserted-by":"crossref","first-page":"380","DOI":"10.1111\/j.1755-5949.2011.00253.x","article-title":"Patient diaries as a clinical endpoint in Parkinson's disease clinical trials","volume":"18","author":"Papapetropoulos","year":"2012","journal-title":"CNS Neurosci Ther"},{"key":"2022110304312219000_11.7.e045272.8","doi-asserted-by":"publisher","DOI":"10.1002\/mds.25628"},{"key":"2022110304312219000_11.7.e045272.9","doi-asserted-by":"crossref","unstructured":"Sam A , P\u00e9rez-L\u00f3pez C , Rodr\u00edguez-Mart\u00edn D .\n                            Estimating bradykinesia severity in Parkinson\u2019s disease by analysing\n                            gait through a waist-worn sensor. 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