Muscular Changes in the First 12 Weeks After Stroke.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Longitudinal prospective cohort study.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Functional Ambulation Categories (FAC)-score [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Muscle volume [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Cross-sectional area (CSA) [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Physiological cross-sectional area (pCSA) [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Muscle tickness [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Fascicle length [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Muscle length [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Tendon length [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Pennation angle [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
- Echo Intensity [Time frame: Frequency: week 1, 5, 8 and 12 after stroke]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 35586876
Identifiers
NCT: NCT06320561 · 23485_StrIMuC12