Dataset Information

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

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.

SUBMITTER: Julliand S

PROVIDER: S-EPMC10946362 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Julliand Sophie S Papaxanthis Charalambos C Delphin Corentin C Mock Anne A Raumel Marc-Antoine MA Gueugnon Mathieu M Ornetti Paul P Laroche Davy D

BMJ open 20240315 3

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This i ...[more]

PMID: 38490651

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Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

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