Longitudinal prospective cohort study
OtherPatients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.
NCT Number: NCT06320561
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.
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)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 2D ultrasound
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 2D ultrasound
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
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through dynamic 2D ultrasound
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through dynamic 2D ultrasound
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through surface electromyography (sEMG)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through surface electromyography (sEMG)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Assessed with a handheld dynamometer (Nm)
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).
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).
Time frame: Frequency: week 1, 5, 8 and 12 after stroke.
Patients will perform the 10-meter walk test while wearing the GaitUp sensors.
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.
Time frame: Within first week after stroke
TWIST gait prediction model scores will be calculated to externally validate this model.
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).
Time frame: Frequency: only during the first assessment (week 1)
Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).
Contact information is provided by the study sponsor or research team.
Vrije Universiteit Brussel
Other
Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.
Acronym: StrIMuC12
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.
Published trials that share one or more normalized conditions with this study.
NCT07735676
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07735702
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07740668
Brain Diseases, Cardiovascular Diseases
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07739264
Brain Diseases, Brain Injuries
Dhaka, Bangladesh
View Trial Details