Muscular Changes in the First 12 Weeks After Stroke.

Stroke Clinical Trial

— StrIMuC12  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320561
• Other study ID #: 23485_StrIMuC12
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Vrije Universiteit Brussel
• Contact: Daan De Vlieger, Msc.
• Phone: +32 (0)2 477 44 89
• Email: daan.de.vlieger[@]vub.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Longitudinal prospective cohort study
Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Research Foundation Flanders, University Ghent

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulation Categories (FAC)-score	Scores ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Muscle volume	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Cross-sectional area (CSA)	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Physiological cross-sectional area (pCSA)	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Muscle tickness	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Fascicle length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Muscle length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Tendon length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Pennation angle	Through 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Echo Intensity	Through 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Dynamic muscle morphology	Dynamic 2D ultrasound used to investigate the changes in cross-sectional area (CSA) en fascicle length	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Change in cross-sectional area	Through dynamic 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Change in fascicle length	Through dynamic 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Average root mean square (RMS)	Through surface electromyography (sEMG)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Peak root mean square (RMS)	Through surface electromyography (sEMG)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Muscle strength	Assessed with a handheld dynamometer (Nm)	Frequency: week 1, 5, 8 and 12 after stroke
Primary	Spasticity	Assessed with the Tardieu Scale. Scores ranging from 0 (no resistance throughout passive movement) to 5 (immobile joint).	Frequency: week 1, 5, 8 and 12 after stroke.
Primary	Lower limb motor impairment	Fugl-Meyer Assessment of the lower limb (FMA LL). Scores ranging from 0 to 34 (no impairment present).	Frequency: week 1, 5, 8 and 12 after stroke.
Primary	Spatiotemporal gait parameters	Patients will perform the 10-meter walk test while wearing the GaitUp sensors.	Frequency: week 1, 5, 8 and 12 after stroke.
Primary	Gait quality	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.	Frequency: only at week 12.
Secondary	TWIST-score	TWIST gait prediction model scores will be calculated to externally validate this model.	Within first week after stroke
Secondary	Knee extension strength	Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).	Frequency: only during the first assessment (week 1).
Secondary	Balance	Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).	Frequency: only during the first assessment (week 1)