Effect of Sarcopenia in Stroke Patients

Stroke Clinical Trial

Official title:

Effect of Sarcopenia in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671705
• Other study ID #: VC22ONDI0185
• Status: Recruiting
• Start date: January 6, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: The Catholic University of Korea
• Contact: Sun Im, MD PhD
• Phone: +*-032-340-2170
• Email: lafolia[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

• 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Stroke

Intervention

Diagnostic Test:
• DEXA Scan
Fu of diagnostic tests

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea	Bucheon-si, Gyeonggi-do
Korea, Republic of	St. Vincent's Hospital	Suwon-si

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Modified Rankin Scale	Functional Disability -> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).	6 months from the first onset of the stroke
Secondary	Hand grip strength	Grip strength: Grip strength will be measured using a dynamometer	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Secondary	quadriceps muscle strength	Lower extremity strength assessment:change in isometric quadriceps muscle strength (kg) from initial evaluation to the final evaluation	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Secondary	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)	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Secondary	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)	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Secondary	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)	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke
Secondary	Brain MRI	Brain atrophy : change in the Global cortical atrophy scale(0-3) of the cerebral cortex from initial evaluation to the final evaluation	within 4 weeks and 6 months from the first onset of the stroke
Secondary	Thigh Dixon MRI	Muscle quality : muscle circumference measured by the thigh MRI from initial evaluation to the final evaluation	within 4 weeks and 6 months from the first onset of the stroke
Secondary	Muscle ultrasonography	muscle thickness(cm) measured by the ultrasound of the quadriceps muscle from initial evaluation to the final evaluation	within 4 weeks and 6 months from the first onset of the stroke
Secondary	serum biomarkers for sarcopenia	BNDF, IL-6	within 4 weeks from the first onset of the stroke
Secondary	Digitalized SEMG signals	state of the art EMG signals will be collected to assess muscle quality changes after stroke	within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke