{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Julliand S"],"funding":["Conseil National de l'ordre des masseur-kinésithérapeute","BIOSERENITY","Dijon University Hospital","French Eastern Interregional Group of Clinical Research and Innovation"],"pagination":["e079918"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10946362"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["14(3)"],"pubmed_abstract":["

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."],"journal":["BMJ open"],"pubmed_title":["IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial."],"pmcid":["PMC10946362"],"funding_grant_id":["N/A","AAP CNOMK - 2022, number N/A","AOI Paramedical 2021, number N/A","GIRCI Est - APPARA 2022, number N/A"],"pubmed_authors":["Papaxanthis C","Raumel MA","Julliand S","Mock A","Delphin C","Laroche D","Gueugnon M","Ornetti P"],"additional_accession":[]},"is_claimable":false,"name":"IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial.","description":"

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.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Mar","modification":"2024-11-06T06:24:16.858Z","creation":"2024-11-06T06:24:16.858Z"},"accession":"S-EPMC10946362","cross_references":{"pubmed":["38490651"],"doi":["10.1136/bmjopen-2023-079918"]}}