Effect of Sarcopenia in Stroke Patients

Completed

• Conditions: Sarcopenia; Stroke

• Registration Number: NCT05671705
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study First Submitted: 2022-11-24
• Study Start: 2023-01-02
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-06-08
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)
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
serum biomarkers for sarcopenia	within 4 weeks from the first onset of the stroke	BNDF, IL-6
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
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
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
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)
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)
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

Trial Locations

Locations (2)

The Catholic University of Korea; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Suwon-si, Korea, Republic of