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NCT Number: NCT06320561

Muscular Changes in the First 12 Weeks After Stroke.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Longitudinal prospective cohort study

Other

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

Primary outcomes

  1. Functional Ambulation Categories (FAC)-score

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Scores ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface)

  2. Muscle volume

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  3. Cross-sectional area (CSA)

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  4. Physiological cross-sectional area (pCSA)

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  5. Muscle tickness

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  6. Fascicle length

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  7. Muscle length

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  8. Tendon length

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 3D freehand ultrasound (3DfUS)

  9. Pennation angle

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 2D ultrasound

  10. Echo Intensity

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through 2D ultrasound

  11. Dynamic muscle morphology

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Dynamic 2D ultrasound used to investigate the changes in cross-sectional area (CSA) en fascicle length

  12. Change in cross-sectional area

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through dynamic 2D ultrasound

  13. Change in fascicle length

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through dynamic 2D ultrasound

  14. Average root mean square (RMS)

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through surface electromyography (sEMG)

  15. Peak root mean square (RMS)

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Through surface electromyography (sEMG)

  16. Muscle strength

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke

    Assessed with a handheld dynamometer (Nm)

  17. Spasticity

    Time frame: Frequency: 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).

  18. Lower limb motor impairment

    Time frame: Frequency: 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).

  19. Spatiotemporal gait parameters

    Time frame: Frequency: week 1, 5, 8 and 12 after stroke.

    Patients will perform the 10-meter walk test while wearing the GaitUp sensors.

  20. Gait quality

    Time frame: Frequency: 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.

Secondary outcomes

  1. TWIST-score

    Time frame: Within first week after stroke

    TWIST gait prediction model scores will be calculated to externally validate this model.

  2. Knee extension strength

    Time frame: Frequency: only during the first assessment (week 1).

    Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).

  3. Balance

    Time frame: Frequency: only during the first assessment (week 1)

    Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).

Study contacts

Contact information is provided by the study sponsor or research team.

Daan De Vlieger, Msc.

CONTACT

[email protected]

+32 (0)2 477 44 89

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Research Foundation Flanders
  • University Ghent

Registry information

Official study title

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

Acronym: StrIMuC12

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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