Clinical trial NCT05671705: Effect of Sarcopenia in Stroke Patients
Official title: Effect of Sarcopenia in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Sarcopenia
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Saint Vincent's Hospital, Korea
First posted: 2023-01-05
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.
* 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.

Eligibility criteria: Inclusion Criteria:

* Patients 65 years of age or older, stroke patients with first onset within 4 weeks

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Modified Rankin Scale
timeFrame: 6 months from the first onset of the stroke
Secondary outcomes:
measure: Hand grip strength
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
measure: quadriceps muscle strength
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
measure: Fugl-Meyer motor scale
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
measure: Functional Ambulation Category
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
measure: Berg balance scale
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
measure: Brain MRI
timeFrame: within 4 weeks and 6 months from the first onset of the stroke
measure: Thigh Dixon MRI
timeFrame: within 4 weeks and 6 months from the first onset of the stroke
measure: Muscle ultrasonography
timeFrame: within 4 weeks and 6 months from the first onset of the stroke
measure: serum biomarkers for sarcopenia
timeFrame: within 4 weeks from the first onset of the stroke
measure: Digitalized SEMG signals
timeFrame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Other outcomes:
Locations:
city: Bucheon-si, Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital
Study officials:
References: