Effect of Sarcopenia in Stroke Patients

Sponsor
The Catholic University of Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT05671705
Collaborator
Saint Vincent's Hospital, Korea (Other)
88
2
17
44
2.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DEXA Scan

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

Study Type:
Observational
Anticipated Enrollment :
88 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Sarcopenia in Stroke Patients
Actual Study Start Date :
Jan 2, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Stroke patients with sarcopenia

Group will be stratified according to gender

Diagnostic Test: DEXA Scan
Fu of diagnostic tests
Other Names:
  • Serum biomarkers, SEMG signals and MRI changes
  • Stroke patients without sarcopenia

    Group will be stratified according to gender

    Diagnostic Test: DEXA Scan
    Fu of diagnostic tests
    Other Names:
  • Serum biomarkers, SEMG signals and MRI changes
  • Outcome Measures

    Primary Outcome Measures

    1. Change of Modified Rankin Scale [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 Outcome Measures

    1. Hand grip strength [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 [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 [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 [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 [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 [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 [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 [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 [within 4 weeks from the first onset of the stroke]

      BNDF, IL-6

    10. Digitalized SEMG signals [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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-BarrĂ© syndrome or myasthenia gravis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea Bucheon-si, Gyeonggi-do Korea, Republic of 14647
    2 St. Vincent's Hospital Suwon-si Korea, Republic of 16247

    Sponsors and Collaborators

    • The Catholic University of Korea
    • Saint Vincent's Hospital, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Im, MD., PhD., The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT05671705
    Other Study ID Numbers:
    • VC22ONDI0185
    First Posted:
    Jan 5, 2023
    Last Update Posted:
    Jan 5, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2023