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Muscular Changes in the First 12 Weeks After Stroke.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06320561
Acronym
StrIMuC12
Enrollment
100
Registered
2024-03-20
Start date
2024-05-31
Completion date
2027-05-31
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Muscular changes, m. rectus femoris, m. gastrocnemius medials, Lower limb impairment, Gait recovery, Subacute phase, 3DfUS, sEMG, Dynamic ultrasound

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.

Interventions

Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.

Sponsors

University Ghent
CollaboratorOTHER
Research Foundation Flanders
CollaboratorOTHER
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait qualityFrequency: only at week 12.Gait profile score (index number in degrees (°)), calculated from the lower limbs' kinematics (3D gait analysis). A higher score means more deviation of the expected (normal) gait pattern.
SpasticityFrequency: week 1, 5, 8 and 12 after stroke.Assessed with the Tardieu Scale. Scores ranging from 0 (no resistance throughout passive movement) to 5 (immobile joint).
Lower limb motor impairmentFrequency: week 1, 5, 8 and 12 after stroke.Fugl-Meyer Assessment of the lower limb (FMA LL). Scores ranging from 0 to 34 (no impairment present).
Spatiotemporal gait parametersFrequency: week 1, 5, 8 and 12 after stroke.Patients will perform the 10-meter walk test while wearing the GaitUp sensors.
Functional Ambulation Categories (FAC)-scoreFrequency: week 1, 5, 8 and 12 after strokeScores ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface)
Muscle volumeFrequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Cross-sectional area (CSA)Frequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Physiological cross-sectional area (pCSA)Frequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Muscle ticknessFrequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Fascicle lengthFrequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Muscle lengthFrequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Tendon lengthFrequency: week 1, 5, 8 and 12 after strokeThrough 3D freehand ultrasound (3DfUS)
Pennation angleFrequency: week 1, 5, 8 and 12 after strokeThrough 2D ultrasound
Echo IntensityFrequency: week 1, 5, 8 and 12 after strokeThrough 2D ultrasound
Dynamic muscle morphologyFrequency: week 1, 5, 8 and 12 after strokeDynamic 2D ultrasound used to investigate the changes in cross-sectional area (CSA) en fascicle length
Change in cross-sectional areaFrequency: week 1, 5, 8 and 12 after strokeThrough dynamic 2D ultrasound
Change in fascicle lengthFrequency: week 1, 5, 8 and 12 after strokeThrough dynamic 2D ultrasound
Average root mean square (RMS)Frequency: week 1, 5, 8 and 12 after strokeThrough surface electromyography (sEMG)
Peak root mean square (RMS)Frequency: week 1, 5, 8 and 12 after strokeThrough surface electromyography (sEMG)
Muscle strengthFrequency: week 1, 5, 8 and 12 after strokeAssessed with a handheld dynamometer (Nm)

Secondary

MeasureTime frameDescription
Knee extension strengthFrequency: only during the first assessment (week 1).Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).
BalanceFrequency: only during the first assessment (week 1)Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).
TWIST-scoreWithin first week after strokeTWIST gait prediction model scores will be calculated to externally validate this model.

Contacts

Primary ContactDaan De Vlieger, Msc.
daan.de.vlieger@vub.be+32 (0)2 477 44 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026