Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.

Vrije Universiteit Brussel0 个研究点目标入组 100 人开始时间: 2024年5月最近更新: 2024年3月20日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Vrije Universiteit Brussel
入组人数: 100
主要终点: Cross-sectional area (CSA)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery.

详细描述

During this longitudinal study, patients who suffer their first-ever stroke will be included within the first week after their stroke (if the inclusion criteria are met). Thereafter, each participant will be assessed at four pre-determined time-points: week 1, 5, 8 and 12 after stroke.

On each of the four time-points, the investigators will assess muscle specific parameters of the affected m. rectus femoris (RF) and m. gastrocnemius medialis (GM), together with clinical tests to assess lower limb impairment (Fugl-Meyer Assessment for the lower limb and the Tardieu scale) and gait parameters (10-meter walk test). Specifically, muscle specific parameters will be investigated using 3D freehand ultrasound (3DfUS) and combined dynamic 2D US and surface electromyography (sEMG). Such assessments will help us characterize the electromechanical properties of these muscles, their time-related trajectories and the relationship with the recovery of gait and lower limb function after stroke. At the end of the investigation period, after 3 months, patients who can walk independently will perform a 3D gait analysis. As such, the relationship between changes in muscle specific parameters and the eventual gait quality at the end of the investigation period will be investigated.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adults (≥ 18 years old)
•Diagnosed with a first-ever stroke (as defined by WHO)
•Stroke onset ≤ 1 week (± 3 days)
•Able to provide written or verbal informed consent at admission
•Presence of gait problems as a consequence of the stroke (FAC≤4)

排除标准

•Presence of other neurological or orthopedic problems present prior to, or not caused as a direct consequence of, the stroke leading to impaired gait.
•Modified Ranking scale pre-stroke > 1/6, meaning presence of slight disability before the stroke.
•Presence of severe comorbidities (e.g. osteoporosis, cardiovascular instability or chronic obstructive pulmonary disease).
•Cerebellar or bilateral stroke.
•Presence of severe deficits in communication, memory or understanding precluding informed consent.