Muscular Changes in the First 12 Weeks After Stroke. (StrIMuC12)

Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Longitudinal prospective cohort study

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Daan De Vlieger, Msc.; Phone Number: +32 (0)2 477 44 89; Email: daan.de.vlieger@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons who suffer their first-ever stroke (ischaemic or hemorrhagic) will be investigated during the subacute phase after the stroke (i.e. first 3 months).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients in the first 3 months after stroke; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Muscle volume	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Cross-sectional area (CSA)	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Physiological cross-sectional area (pCSA)	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Muscle tickness	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Fascicle length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Muscle length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Tendon length	Through 3D freehand ultrasound (3DfUS)	Frequency: week 1, 5, 8 and 12 after stroke
Pennation angle	Through 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Echo Intensity	Through 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
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
Change in cross-sectional area	Through dynamic 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Change in fascicle length	Through dynamic 2D ultrasound	Frequency: week 1, 5, 8 and 12 after stroke
Average root mean square (RMS)	Through surface electromyography (sEMG)	Frequency: week 1, 5, 8 and 12 after stroke
Peak root mean square (RMS)	Through surface electromyography (sEMG)	Frequency: week 1, 5, 8 and 12 after stroke
Muscle strength	Assessed with a handheld dynamometer (Nm)	Frequency: week 1, 5, 8 and 12 after stroke
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TWIST-score	TWIST gait prediction model scores will be calculated to externally validate this model.	Within first week after stroke
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).
Balance	Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).	Frequency: only during the first assessment (week 1)

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: University Ghent; Research Foundation Flanders
• Investigators: Principal Investigator: Eva Swinnen, Professor, Vrije Universiteit Brussel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sEMG; Subacute phase; Muscular changes; m. rectus femoris; m. gastrocnemius medials; Lower limb impairment; Gait recovery; 3DfUS; Dynamic ultrasound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 23485_StrIMuC12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No