Muscular Changes in the First 12 Weeks After Stroke.
- Conditions
- Stroke
- Interventions
- Other: Longitudinal prospective cohort study
- Registration Number
- NCT06320561
- Lead Sponsor
- Vrije Universiteit Brussel
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients in the first 3 months after stroke Longitudinal prospective cohort study 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 Outcome Measures
Name Time Method Tendon length Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Echo Intensity Frequency: week 1, 5, 8 and 12 after stroke Through 2D ultrasound
Dynamic muscle morphology 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
Functional Ambulation Categories (FAC)-score 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)
Muscle tickness Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Muscle volume Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Fascicle length Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Pennation angle Frequency: week 1, 5, 8 and 12 after stroke Through 2D ultrasound
Cross-sectional area (CSA) Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Change in cross-sectional area Frequency: week 1, 5, 8 and 12 after stroke Through dynamic 2D ultrasound
Change in fascicle length Frequency: week 1, 5, 8 and 12 after stroke Through dynamic 2D ultrasound
Peak root mean square (RMS) Frequency: week 1, 5, 8 and 12 after stroke Through surface electromyography (sEMG)
Muscle length Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Spasticity 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).
Average root mean square (RMS) Frequency: week 1, 5, 8 and 12 after stroke Through surface electromyography (sEMG)
Muscle strength Frequency: week 1, 5, 8 and 12 after stroke Assessed with a handheld dynamometer (Nm)
Gait quality 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.
Physiological cross-sectional area (pCSA) Frequency: week 1, 5, 8 and 12 after stroke Through 3D freehand ultrasound (3DfUS)
Lower limb motor impairment 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).
Spatiotemporal gait parameters Frequency: week 1, 5, 8 and 12 after stroke. Patients will perform the 10-meter walk test while wearing the GaitUp sensors.
- Secondary Outcome Measures
Name Time Method Knee extension strength Frequency: only during the first assessment (week 1). Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).
Balance Frequency: only during the first assessment (week 1) Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).
TWIST-score Within first week after stroke TWIST gait prediction model scores will be calculated to externally validate this model.