NCT06320561Not yet recruiting
Muscular Changes in the First 12 Weeks After Stroke.
Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.
Source: ClinicalTrials.gov · Last updated 20 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 12 Jan 2024
- Start date
- 1 May 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Vrije Universiteit Brussel
- Diseases
- Stroke
- NCT number
- NCT06320561
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 May 2024 to the primary completion date, 31 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of other neurological or orthopedic problems present prior to, or not caused as a direct consequence of, the stroke leading to impaired gait.
Other illness
- 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.
Other
- Presence of severe deficits in communication, memory or understanding precluding informed consent.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.