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Completed

NCT Number: NCT05671705

Effect of Sarcopenia in Stroke Patients

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

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Key information

Conditions

Stroke Atrophy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University of Korea, Bucheon-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexa scan

Diagnostic Test

Fu of diagnostic tests

Other names: Serum biomarkers, SEMG signals and MRI changes

Primary outcomes

  1. 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).

Secondary outcomes

  1. Hand grip strength

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    Grip strength: Grip strength will be measured using a dynamometer

  2. quadriceps muscle strength

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    Lower extremity strength assessment:change in isometric quadriceps muscle strength (kg) from initial evaluation to the final evaluation

  3. Fugl-Meyer motor scale

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    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)

  4. Functional Ambulation Category

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    Gait function assessment : Functional Ambulation Category from initial evaluation to the final evaluation (Minimum 0, Maximum 5; Higher score means better outcome)

  5. Berg balance scale

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    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)

  6. Brain MRI

    Time frame: within 4 weeks and 6 months from the first onset of the stroke

    Brain atrophy : change in the Global cortical atrophy scale(0-3) of the cerebral cortex from initial evaluation to the final evaluation

  7. Thigh Dixon MRI

    Time frame: within 4 weeks and 6 months from the first onset of the stroke

    Muscle quality : muscle circumference measured by the thigh MRI from initial evaluation to the final evaluation

  8. Muscle ultrasonography

    Time frame: within 4 weeks and 6 months from the first onset of the stroke

    muscle thickness(cm) measured by the ultrasound of the quadriceps muscle from initial evaluation to the final evaluation

  9. serum biomarkers for sarcopenia

    Time frame: within 4 weeks from the first onset of the stroke

    BNDF, IL-6

  10. Digitalized SEMG signals

    Time frame: within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke

    state of the art EMG signals will be collected to assess muscle quality changes after stroke

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

  • Saint Vincent's Hospital, Korea

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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