StrokeStrIMuC12NCT06320561
Muscular Changes in the First 12 Weeks After Stroke.
An observational study of Stroke, run by Vrije Universiteit Brussel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Longitudinal prospective cohort study
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Longitudinal prospective cohort study
- Keywords
- Muscular changes, m. rectus femoris, m. gastrocnemius medials, Lower limb impairment, Gait recovery, Subacute phase, 3DfUS, sEMG, Dynamic ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal prospective cohort studyOther
Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Longitudinal prospective cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Categories (FAC)-score
Scores ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Muscle volume
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Cross-sectional area (CSA)
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Physiological cross-sectional area (pCSA)
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Muscle tickness
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Fascicle length
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Muscle length
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Tendon length
Through 3D freehand ultrasound (3DfUS)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Pennation angle
Through 2D ultrasound
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Echo Intensity
Through 2D ultrasound
Measured: 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
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Change in cross-sectional area
Through dynamic 2D ultrasound
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Change in fascicle length
Through dynamic 2D ultrasound
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Average root mean square (RMS)
Through surface electromyography (sEMG)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Peak root mean square (RMS)
Through surface electromyography (sEMG)
Measured: Frequency: week 1, 5, 8 and 12 after stroke
Muscle strength
Assessed with a handheld dynamometer (Nm)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Frequency: only at week 12.
Secondary outcomes (3)
TWIST-score
TWIST gait prediction model scores will be calculated to externally validate this model.
Measured: Within first week after stroke
Knee extension strength
Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).
Measured: Frequency: only during the first assessment (week 1).
Balance
Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).
Measured: Frequency: only during the first assessment (week 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Research Foundation Flanders
- Responsible party
- Principal investigator, Eva Swinnen, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Professor, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320561
- Sponsor's protocol ID
- 23485_StrIMuC12
- Acronym
- StrIMuC12
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35586876
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.
- ClinicalTrials.gov ID
- NCT06320561
- Acronym / sponsor ID
- StrIMuC12 / 23485_StrIMuC12
- Conditions
- Stroke
- Keywords
- Muscular changes, m. rectus femoris, m. gastrocnemius medials, Lower limb impairment, Gait recovery, Subacute phase, 3DfUS, sEMG
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University Ghent, Research Foundation Flanders
- Study start
- May 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the first 3 months after stroke | – | Other: Longitudinal prospective cohort studyInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal prospective cohort studyPatients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke. | Other | Patients in the first 3 months after stroke |
Primary outcome
Functional Ambulation Categories (FAC)-score
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)
Muscle volume
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Cross-sectional area (CSA)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Physiological cross-sectional area (pCSA)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Muscle tickness
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Fascicle length
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Muscle length
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Tendon length
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 3D freehand ultrasound (3DfUS)
Pennation angle
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 2D ultrasound
Echo Intensity
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through 2D ultrasound
Dynamic muscle morphology
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
Change in cross-sectional area
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through dynamic 2D ultrasound
Change in fascicle length
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through dynamic 2D ultrasound
Average root mean square (RMS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through surface electromyography (sEMG)
Peak root mean square (RMS)
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Through surface electromyography (sEMG)
Muscle strength
Time frame: Frequency: week 1, 5, 8 and 12 after stroke
Assessed with a handheld dynamometer (Nm)
Spasticity
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).
Lower limb motor impairment
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).
Spatiotemporal gait parameters
Time frame: Frequency: week 1, 5, 8 and 12 after stroke.
Patients will perform the 10-meter walk test while wearing the GaitUp sensors.
Gait quality
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.
3 secondary outcomes
TWIST-score
Time frame: Within first week after stroke
Knee extension strength
Time frame: Frequency: only during the first assessment (week 1).
Balance
Time frame: Frequency: only during the first assessment (week 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 35586876Smith 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Swinnen, Professor principal investigator
Vrije Universiteit Brussel
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Vrije Universiteit Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daan De Vlieger, Msc. (+32 (0)2 477 44 89, daan.de.vlieger@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Categories (FAC)-score (time frame: Frequency: week 1, 5, 8 and 12 after stroke). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.