{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T16:16:50Z","timestamp":1790093810835,"version":"4.0.1"},"reference-count":44,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,15]],"date-time":"2024-03-15T00:00:00Z","timestamp":1710460800000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"BIOSERENITY","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Conseil National de l'ordre des masseur-kin\u00e9sith\u00e9rapeute","award":["AAP CNOMK - 2022, number N\/A"],"award-info":[{"award-number":["AAP CNOMK - 2022, number N\/A"]}]},{"name":"French Eastern Interregional Group of Clinical Research and Innovation","award":["GIRCI Est - APPARA 2022, number N\/A"],"award-info":[{"award-number":["GIRCI Est - APPARA 2022, number N\/A"]}]},{"name":"Dijon University Hospital","award":["AOI Paramedical 2021, number N\/A"],"award-info":[{"award-number":["AOI Paramedical 2021, number N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,27]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Spasticity is a frequent disabling consequence following a stroke. Local muscle vibrations (LMVs) have been proposed as a treatment to address this problem. However, little is known about their clinical and neurophysiological impacts when used repeatedly during the subacute phase post-stroke. This project aims to evaluate the effects of a 6-week LMV protocol on the paretic limb on spasticity development in a post-stroke subacute population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This is an interventional, controlled, randomised, single-blind (patient) trial. 100 participants over 18 years old will be recruited, within 6 weeks following a first stroke with hemiparesis or hemiplegia. All participants will receive a conventional rehabilitation programme, plus 18 sessions of LMV (ie, continuously for 30\u2009min) on relaxed wrist and elbow flexors: either (1) at 80\u2009Hz for the interventional group or (2) at 40\u2009Hz plus a foam band between the skin and the device for the control group.<\/jats:p><jats:p>Participants will be evaluated at baseline, at 3 weeks and 6 weeks, and at 6 months after the end of the intervention. Spasticity will be measured by the modified Ashworth scale and with an isokinetic dynamometer. Sensorimotor function will be assessed with the Fugl-Meyer assessment of the upper extremity. Corticospinal and spinal excitabilities will be measured each time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This study was recorded in a clinical trial and obtained approval from the institutional review board (Comit\u00e9 de protection des personnes Ile de France IV, 2021-A03219-32). All participants will be required to provide informed consent. The results of this trial will be published in peer-reviewed journals to disseminate information to clinicians and impact their practice for an improved patient\u2019s care.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>Clinical Trial:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05315726\">NCT05315726<\/jats:ext-link><\/jats:p><\/jats:sec><jats:sec><jats:title>Dataset<\/jats:title><jats:p>EUDRAct<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-079918","type":"journal-article","created":{"date-parts":[[2024,3,15]],"date-time":"2024-03-15T14:50:34Z","timestamp":1710514234000},"page":"e079918","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05315726","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05315726","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-8916-7386","authenticated-orcid":false,"given":"Sophie","family":"Julliand","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charalambos","family":"Papaxanthis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corentin","family":"Delphin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Mock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc-Antoine","family":"Raumel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Gueugnon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Ornetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davy","family":"Laroche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,3,15]]},"reference":[{"key":"2024043021521156000_14.3.e079918.1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(21)00252-0"},{"key":"2024043021521156000_14.3.e079918.2","doi-asserted-by":"crossref","DOI":"10.1155\/2014\/354906","article-title":"Pathophysiology of spasticity: implications for neurorehabilitation","volume":"2014","author":"Trompetto","year":"2014","journal-title":"Biomed Res Int"},{"key":"2024043021521156000_14.3.e079918.3","doi-asserted-by":"crossref","DOI":"10.3389\/fneur.2020.616097","article-title":"Prevalence and risk factors for spasticity after stroke: a systematic review and meta-analysis","volume":"11","author":"Zeng","year":"2020","journal-title":"Front Neurol"},{"key":"2024043021521156000_14.3.e079918.4","doi-asserted-by":"publisher","DOI":"10.1080\/09638280400014576"},{"key":"2024043021521156000_14.3.e079918.5","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-1331.2002.0090s1003.x"},{"key":"2024043021521156000_14.3.e079918.6","doi-asserted-by":"crossref","DOI":"10.3389\/fneur.2019.00468","article-title":"A unifying pathophysiological account for post-stroke spasticity and disordered motor control","volume":"10","author":"Li","year":"2019","journal-title":"Front Neurol"},{"key":"2024043021521156000_14.3.e079918.7","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1111\/j.1468-1331.2011.03448.x","article-title":"A literature review of the pathophysiology and onset of post-stroke spasticity: post-stroke spasticity: pathophysiology and onset","volume":"19","author":"Ward","year":"2012","journal-title":"Eur J Neurol Janv"},{"key":"2024043021521156000_14.3.e079918.8","doi-asserted-by":"publisher","DOI":"10.2340\/16501977-0509"},{"key":"2024043021521156000_14.3.e079918.9","doi-asserted-by":"publisher","DOI":"10.1097\/PHM.0000000000000157"},{"key":"2024043021521156000_14.3.e079918.10","doi-asserted-by":"crossref","first-page":"508","DOI":"10.1080\/10749357.2020.1843845","article-title":"Early clinical predictors of post stroke spasticity","volume":"28","author":"Glaess-Leistner","year":"2021","journal-title":"Top Stroke Rehabil"},{"key":"2024043021521156000_14.3.e079918.11","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/j.physio.2019.01.004","article-title":"Predictors of upper limb spasticity after stroke? A systematic review and meta-analysis","volume":"105","author":"Tedesco Triccas","year":"2019","journal-title":"Physiotherapy"},{"key":"2024043021521156000_14.3.e079918.12","article-title":"Pharmacological interventions other than botulinum toxin for spasticity after stroke","volume":"10","author":"Lindsay","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"2024043021521156000_14.3.e079918.13","doi-asserted-by":"crossref","unstructured":"Sanchetee P . Current trends in stroke rehabilitation. In: Sanchetee P , ed. Ischemic Stroke. IntechOpen, 2021. doi:10.5772\/intechopen.86623","DOI":"10.5772\/intechopen.95576"},{"key":"2024043021521156000_14.3.e079918.14","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.jocn.2017.02.044","article-title":"Breakthroughs in the spasticity management: are non-pharmacological treatments the future","volume":"39","author":"Naro","year":"2017","journal-title":"J Clin Neurosci"},{"key":"2024043021521156000_14.3.e079918.15","doi-asserted-by":"crossref","unstructured":"Roll JP , Vedel JP , Ribot E . Alteration of proprioceptive messages induced by tendon vibration in man: a microneurographic study. Exp Brain Res 1989;76. doi:10.1007\/BF00253639 Available: http:\/\/link.springer.com\/10.1007\/BF00253639","DOI":"10.1007\/BF00253639"},{"key":"2024043021521156000_14.3.e079918.16","doi-asserted-by":"crossref","first-page":"1157","DOI":"10.1002\/cphy.c170036","article-title":"Kinesthesic senses","volume":"8","author":"Proske","year":"2018","journal-title":"Compr Physiol"},{"key":"2024043021521156000_14.3.e079918.17","doi-asserted-by":"crossref","first-page":"1137","DOI":"10.1152\/jn.00168.2021","article-title":"Vibration decreases the responsiveness of IA afferents and spinal motoneurons in humans","volume":"126","author":"Nito","year":"2021","journal-title":"J Neurophysiol"},{"key":"2024043021521156000_14.3.e079918.18","doi-asserted-by":"crossref","first-page":"1939","DOI":"10.1007\/s00421-017-3688-8","article-title":"Acute and chronic neuromuscular adaptations to local vibration training","volume":"117","author":"Souron","year":"2017","journal-title":"Eur J Appl Physiol"},{"key":"2024043021521156000_14.3.e079918.19","doi-asserted-by":"crossref","DOI":"10.3389\/fnhum.2021.617669","article-title":"Indirect vibration of the upper limbs alters transmission along spinal but not corticospinal pathways","volume":"15","author":"Barss","year":"2021","journal-title":"Front Hum Neurosci"},{"key":"2024043021521156000_14.3.e079918.20","doi-asserted-by":"crossref","first-page":"254","DOI":"10.3109\/08990220.2015.1091770","article-title":"The effects of acute and prolonged muscle vibration on the function of the muscle spindle\u2019s reflex arc","volume":"32","author":"Pope","year":"2015","journal-title":"Somatosens Mot Res"},{"key":"2024043021521156000_14.3.e079918.21","doi-asserted-by":"crossref","first-page":"5143","DOI":"10.1113\/JP278837","article-title":"On the loop again: understanding human spinal circuitry through the study of its reflex pathway","volume":"597","author":"Grospr\u00eatre","year":"2019","journal-title":"J Physiol"},{"key":"2024043021521156000_14.3.e079918.22","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0185936","article-title":"Is two better than one? Muscle vibration plus robotic rehabilitation to improve upper limb spasticity and function: a pilot randomized controlled trial","volume":"12","author":"Calabr\u00f2","year":"2017","journal-title":"PLOS ONE"},{"key":"2024043021521156000_14.3.e079918.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.jelekin.2005.09.001"},{"key":"2024043021521156000_14.3.e079918.24","doi-asserted-by":"publisher","DOI":"10.23736\/S1973-9087.20.06390-X"},{"key":"2024043021521156000_14.3.e079918.25","doi-asserted-by":"publisher","DOI":"10.1177\/1545968310376757"},{"key":"2024043021521156000_14.3.e079918.26","doi-asserted-by":"publisher","DOI":"10.1053\/apmr.2002.35473"},{"key":"2024043021521156000_14.3.e079918.27","doi-asserted-by":"crossref","DOI":"10.3389\/fneur.2019.00115","article-title":"Short-term effects of focal muscle vibration on motor recovery after acute stroke: a pilot randomized sham-controlled study","volume":"10","author":"Toscano","year":"2019","journal-title":"Front Neurol"},{"key":"2024043021521156000_14.3.e079918.28","doi-asserted-by":"crossref","first-page":"558","DOI":"10.23736\/S1973-9087.19.05605-3","article-title":"Upper limb tendon\/muscle vibration in persons with subacute and chronic stroke: a systematic review and meta-analysis","volume":"55","author":"Mortaza","year":"2019","journal-title":"Eur J Phys Rehabil Med"},{"key":"2024043021521156000_14.3.e079918.29","doi-asserted-by":"crossref","unstructured":"Meseguer-Henarejos AB , S\u00e1nchez-Meca J , L\u00f3pez-Pina JA , et al . n.d. Inter- and intra-rater reliability of the modified Ashworth scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med;54. doi:10.23736\/S1973-9087.17.04796-7 Available: https:\/\/www.minervamedica.it\/index2.php?show=R33Y2018N04A0576","DOI":"10.23736\/S1973-9087.17.04796-7"},{"key":"2024043021521156000_14.3.e079918.30","doi-asserted-by":"publisher","DOI":"10.1093\/ptj\/67.2.206"},{"key":"2024043021521156000_14.3.e079918.31","doi-asserted-by":"publisher","DOI":"10.1191\/0269215505cr832oa"},{"key":"2024043021521156000_14.3.e079918.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.apmr.2015.06.009"},{"key":"2024043021521156000_14.3.e079918.33","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.jbmt.2020.02.011","article-title":"Test-retest reliability and responsiveness of isokinetic dynamometry to assess wrist Flexor muscle spasticity in subacute post-stroke hemiparesis","volume":"24","author":"Salehi Dehno","year":"2020","journal-title":"J Bodyw Mov Ther"},{"key":"2024043021521156000_14.3.e079918.34","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.116.015790"},{"key":"2024043021521156000_14.3.e079918.35","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1159\/000499133","article-title":"Effects of acupuncture treatment on lower limb spasticity in patients following hemorrhagic stroke: a pilot study","volume":"81","author":"Wang","year":"2019","journal-title":"Eur Neurol"},{"key":"2024043021521156000_14.3.e079918.36","doi-asserted-by":"publisher","DOI":"10.1152\/jn.00611.2011"},{"key":"2024043021521156000_14.3.e079918.37","doi-asserted-by":"publisher","DOI":"10.2340\/16501977-0946"},{"key":"2024043021521156000_14.3.e079918.38","first-page":"e33","article-title":"Focal muscle vibration and progressive modular rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb","volume":"168","author":"Celletti","year":"2017","journal-title":"Clin Ter"},{"key":"2024043021521156000_14.3.e079918.39","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.74.5.646"},{"key":"2024043021521156000_14.3.e079918.40","doi-asserted-by":"crossref","first-page":"410","DOI":"10.1016\/j.apmr.2004.10.022","article-title":"Evaluation of upper-limb spasticity after stroke: a clinical and neurophysiologic study","volume":"86","author":"Pizzi","year":"2005","journal-title":"Arch Phys Med Rehabil"},{"key":"2024043021521156000_14.3.e079918.41","doi-asserted-by":"publisher","DOI":"10.1016\/S0926-6410(02)00221-5"},{"key":"2024043021521156000_14.3.e079918.42","doi-asserted-by":"publisher","DOI":"10.1016\/j.neures.2015.10.013"},{"key":"2024043021521156000_14.3.e079918.43","doi-asserted-by":"publisher","DOI":"10.1080\/00222895.2016.1271305"},{"key":"2024043021521156000_14.3.e079918.44","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1007\/s13760-023-02377-w","article-title":"Corticospinal tract: a new hope for the treatment of post-stroke spasticity","volume":"124","author":"Huang","year":"2024","journal-title":"Acta Neurol Belg"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-079918","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T05:13:44Z","timestamp":1714540424000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-079918"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3]]},"references-count":44,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,3,15]]},"published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1136\/bmjopen-2023-079918"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-079918","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3]]}}}