IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial.

Autor:	Julliand S; INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France sophie.julliand@chu-dijon.fr.; INSERM U1093, Dijon, France., Papaxanthis C; INSERM U1093, Dijon, France., Delphin C; INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France., Mock A; Physical Medicine and Rehabilitation, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France., Raumel MA; Physical Medicine and Rehabilitation, Hospital Centre Chalon-sur-Saône, Chalon-sur-Saône, France., Gueugnon M; INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France.; INSERM U1093, Dijon, France., Ornetti P; INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France.; INSERM U1093, Dijon, France., Laroche D; INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France.; INSERM U1093, Dijon, France.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Mar 15; Vol. 14 (3), pp. e079918. Date of Electronic Publication: 2024 Mar 15.
DOI:	10.1136/bmjopen-2023-079918
Abstrakt:	Introduction: 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. Methods and Analysis: 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 min) on relaxed wrist and elbow flexors: either (1) at 80 Hz for the interventional group or (2) at 40 Hz plus a foam band between the skin and the device for the control group.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. Ethics and Dissemination: This study was recorded in a clinical trial and obtained approval from the institutional review board (Comité 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's care. Trial Registration Number: Clinical Trial: NCT05315726 DATASET: EUDRAct. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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