StrokeNCT05671705
Effect of Sarcopenia in Stroke Patients
An observational study of Stroke and Sarcopenia, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
Primary research purpose: -Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery Secondary research purpose: To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Sarcopenia
- What is being tested?
- DEXA Scan
- How many people
- 83 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 2 Jan 2023to 27 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Recruited subjects will be allocated into 4 different groups according to presence of sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria. * Post stroke male patients with sarcopenia * Post stroke female patients with sarcopenia * Post stroke male patients without sarcopenia * Post stroke female patients without sarcopenia
Who may be able to join
- Patients 65 years of age or older, stroke patients with first onset within 4 weeks
Who cannot join
- Patients who have not been evaluated for sarcopenia
- Patients with neuromuscular diseases other than stroke that may affect gait function
- Patients unable to conduct clinical trials according to instructions
- Patients with uncontrolled medical/surgical disease
- Patients with metal substances in the body such as cardiac pacemakers, cochlear implants, etc.
- Patients who have difficulty collecting blood
- Patients who are difficult to follow up after 6 months of onset due to moving to another area
- Patients who have Parkinson's disease, dementia, or have a history of neuromuscular diseases such as Guillain-Barré syndrome or myasthenia gravis
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
The Catholic University of Korea
Bucheon-si, Gyeonggi-do, 14647
St. Vincent's Hospital
Suwon, 16247
About this study
Primary research purpose:
-Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery
Secondary research purpose:
- To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group.
- To determine the degree of sarcopenia and correlation with dixon MRI of thigh muscle
- To evaluate surface EMG (SEMG)-based signals and correlation with sarcopenia
- To determine the degree of sarcopenia and correlation with brain morphometric changes
Read the detailed description
Patients with first-ever stroke will be enrolled and assessed for sarcopenia. The evaluation parameters will include standard sarcopenia parameters and also SEMG-based signals and imaging studies.
- Conditions
- Stroke, Sarcopenia
- Being tested
- DEXA Scan
- Medical subject headings
- Stroke, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA ScanDiagnostic test
Also called Serum biomarkers, SEMG signals and MRI changes
Fu of diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients with sarcopenia | Group will be stratified according to gender Receives: Diagnostic Test: DEXA Scan | |
| Stroke patients without sarcopenia | Group will be stratified according to gender Receives: Diagnostic Test: DEXA Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Modified Rankin Scale
Functional Disability -> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).
Measured: 6 months from the first onset of the stroke
Secondary outcomes (10)
Hand grip strength
Grip strength: Grip strength will be measured using a dynamometer
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
quadriceps muscle strength
Lower extremity strength assessment:change in isometric quadriceps muscle strength (kg) from initial evaluation to the final evaluation
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Fugl-Meyer motor scale
Motor function assessment : Fugl-Meyer motor scale from initial evaluation to the final evaluation (Upper Extremity maximum score = 66; Lower Extremity maximum score = 34, Higher score means better outcome)
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Functional Ambulation Category
Gait function assessment : Functional Ambulation Category from initial evaluation to the final evaluation (Minimum 0, Maximum 5; Higher score means better outcome)
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Berg balance scale
Balance function: change in Berg balance scale from initial evaluation to the final evaluation (Minimum score 0, Maximum score 56, Higher score means better outcome)
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Brain MRI
Brain atrophy : change in the Global cortical atrophy scale(0-3) of the cerebral cortex from initial evaluation to the final evaluation
Measured: within 4 weeks and 6 months from the first onset of the stroke
Thigh Dixon MRI
Muscle quality : muscle circumference measured by the thigh MRI from initial evaluation to the final evaluation
Measured: within 4 weeks and 6 months from the first onset of the stroke
Muscle ultrasonography
muscle thickness(cm) measured by the ultrasound of the quadriceps muscle from initial evaluation to the final evaluation
Measured: within 4 weeks and 6 months from the first onset of the stroke
serum biomarkers for sarcopenia
BNDF, IL-6
Measured: within 4 weeks from the first onset of the stroke
Digitalized SEMG signals
state of the art EMG signals will be collected to assess muscle quality changes after stroke
Measured: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start2 Jan 2023
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671705
- Sponsor's protocol ID
- VC22ONDI0185
- Status last verified
- Jan 2025
- First submitted
- 24 Nov 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarcopenia in Stroke Patients
- ClinicalTrials.gov ID
- NCT05671705
- Acronym / sponsor ID
- VC22ONDI0185
- Conditions
- Stroke, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 5 Jan 2023 (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.
Primary research purpose:
-Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery
Secondary research purpose:
- To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group.
- To determine the degree of sarcopenia and correlation with dixon MRI of thigh muscle
- To evaluate surface EMG (SEMG)-based signals and correlation with sarcopenia
- To determine the degree of sarcopenia and correlation with brain morphometric changes
Detailed description
Patients with first-ever stroke will be enrolled and assessed for sarcopenia. The evaluation parameters will include standard sarcopenia parameters and also SEMG-based signals and imaging studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients with sarcopenia | – | Diagnostic Test: DEXA ScanGroup will be stratified according to gender |
| Stroke patients without sarcopenia | – | Diagnostic Test: DEXA ScanGroup will be stratified according to gender |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Recruited subjects will be allocated into 4 different groups according to presence of sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria. * Post stroke male patients with sarcopenia * Post stroke female patients with sarcopenia * Post stroke male patients without sarcopenia * Post stroke female patients without sarcopenia
Key inclusion criteria (1 listed)
- Patients 65 years of age or older, stroke patients with first onset within 4 weeks
Key exclusion criteria (8 listed)
- Patients who have not been evaluated for sarcopenia
- Patients with neuromuscular diseases other than stroke that may affect gait function
- Patients unable to conduct clinical trials according to instructions
- Patients with uncontrolled medical/surgical disease
- Patients with metal substances in the body such as cardiac pacemakers, cochlear implants, etc.
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 |
|---|---|---|
| DEXA ScanAlso: Serum biomarkers, SEMG signals and MRI changesFu of diagnostic tests | Diagnostic test | Stroke patients with sarcopenia, Stroke patients without sarcopenia |
Primary outcome
Change of Modified Rankin Scale
Time frame: 6 months from the first onset of the stroke
Functional Disability -> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).
10 secondary outcomes
Hand grip strength
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
quadriceps muscle strength
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Fugl-Meyer motor scale
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Functional Ambulation Category
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Berg balance scale
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Brain MRI
Time frame: within 4 weeks and 6 months from the first onset of the stroke
Thigh Dixon MRI
Time frame: within 4 weeks and 6 months from the first onset of the stroke
Muscle ultrasonography
Time frame: within 4 weeks and 6 months from the first onset of the stroke
serum biomarkers for sarcopenia
Time frame: within 4 weeks from the first onset of the stroke
Digitalized SEMG signals
Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Sarcopenia, run by The Catholic University of Korea at 2 sites in South Korea.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Modified Rankin Scale (time frame: 6 months from the first onset of the stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.