Clinical trial NCT06320561: Muscular Changes in the First 12 Weeks After Stroke.
Official title: Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: Muscular changes
m. rectus femoris
m. gastrocnemius medials
Lower limb impairment
Gait recovery
Subacute phase
3DfUS
sEMG
Dynamic ultrasound
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Research Foundation Flanders
First posted: 2024-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons who suffer their first-ever stroke (ischaemic or hemorrhagic) will be investigated during the subacute phase after the stroke (i.e. first 3 months).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functional Ambulation Categories (FAC)-score
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Muscle volume
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Cross-sectional area (CSA)
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Physiological cross-sectional area (pCSA)
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Muscle tickness
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Fascicle length
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Muscle length
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Tendon length
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Pennation angle
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Echo Intensity
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Dynamic muscle morphology
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Change in cross-sectional area
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Change in fascicle length
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Average root mean square (RMS)
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Peak root mean square (RMS)
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Muscle strength
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke
measure: Spasticity
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke.
measure: Lower limb motor impairment
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke.
measure: Spatiotemporal gait parameters
timeFrame: Frequency: week 1, 5, 8 and 12 after stroke.
measure: Gait quality
timeFrame: Frequency: only at week 12.
Secondary outcomes:
measure: TWIST-score
timeFrame: Within first week after stroke
measure: Knee extension strength
timeFrame: Frequency: only during the first assessment (week 1).
measure: Balance
timeFrame: Frequency: only during the first assessment (week 1)
Other outcomes:
Locations:
Study officials:
affiliation: Vrije Universiteit Brussel
name: Eva Swinnen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.