Muscular Changes in the First 12 Weeks After Stroke.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Longitudinal prospective cohort study
  Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.

Первичные конечные точки

• Functional Ambulation Categories (FAC)-score [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Muscle volume [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Cross-sectional area (CSA) [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Physiological cross-sectional area (pCSA) [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Muscle tickness [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Fascicle length [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Muscle length [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Tendon length [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Pennation angle [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]
• Echo Intensity [Срок оценки: Frequency: week 1, 5, 8 and 12 after stroke]

Вторичные конечные точки (3)

• TWIST-score [Срок оценки: Within first week after stroke]
• Knee extension strength [Срок оценки: Frequency: only during the first assessment (week 1).]
• Balance [Срок оценки: Frequency: only during the first assessment (week 1)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Smith MC, Barber AP, Scrivener BJ, Stinear CM. The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Neurorehabil Neural Repair. 2022 Jul;36(7):461-471. doi: 10.1177/15459683221085287. Epub 2022 May 18. PMID 35586876

Идентификаторы

NCT: NCT06320561 · 23485_StrIMuC12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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