Muscular Changes in the First 12 Weeks After Stroke.

NCT06320561 | Not Yet Recruiting

• 1 other identifier: 23485_StrIMuC12
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

Muscular changes; m. rectus femoris; m. gastrocnemius medials; Lower limb impairment; Gait recovery; Subacute phase; 3DfUS; sEMG; Dynamic ultrasound

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (3)

• TWIST-score

  Within first week after stroke

• Knee extension strength

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

• Balance

  Frequency: only during the first assessment (week 1)

Study Arms (1)

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

Interventions

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.

Patients in the first 3 months after stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• University Ghent: collaborator
• Research Foundation Flanders: collaborator

Related 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.

  PMID: 35586876 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eva Swinnen, Professor

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daan De Vlieger, Msc.

CONTACT

+32 (0)2 477 44 89; daan.de.vlieger@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-03