INSERM CIC 1432, Plateforme d'Investigation Technologique, CHU Dijon, Dijon, Bourgogne-Franche-Comté, France
INSERM U1093, Dijon, France.
BMJ Open. 2024 Mar 15;14(3):e079918. doi: 10.1136/bmjopen-2023-079918.
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.
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.
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.
Clinical Trial: NCT05315726 DATASET: EUDRAct.
痉挛是中风后常见的致残后果。局部肌肉振动（LMV）已被提议作为一种治疗方法来解决这个问题。然而，在中风后亚急性期反复使用时，其对临床和神经生理学的影响知之甚少。本项目旨在评估为期 6 周的 LMV 方案对偏瘫痉挛肢体的影响，以了解其对亚急性中风患者的痉挛发展的影响。
这是一项干预性、对照、随机、单盲（患者）试验。将招募 100 名 18 岁以上的参与者，在首次中风后 6 周内出现偏瘫或偏瘫。所有参与者将接受常规康复计划，外加 18 次 LMV（即连续 30 分钟），放松腕部和肘部屈肌：干预组为 80Hz，对照组为 40Hz 加皮肤和设备之间的泡沫带。参与者将在基线、3 周和 6 周以及干预结束后 6 个月进行评估。痉挛将通过改良 Ashworth 量表和等速测力计进行测量。感觉运动功能将通过上肢 Fugl-Meyer 评估进行评估。每次都会测量皮质脊髓和脊髓兴奋性。
这项研究已在临床试验中记录，并获得机构审查委员会（法兰西岛 IV 保护委员会，2021-A03219-32）的批准。所有参与者都需要提供知情同意书。该试验的结果将发表在同行评议的期刊上，向临床医生传播信息，并影响他们的实践，以改善患者的护理。
NCT05315726 数据集：EudraCT。
