The impact of electrical stimulation therapy on skeletal muscle quantity and quality decline in acute stroke patients.

UMIN ID: UMIN000056658

Registered date:13/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hospitalized patients immediately after stroke onset.
• Date of first enrollment: 2025/01/13
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the electrical stimulation group, electrical stimulation therapy (at a level where muscle contractions are visibly noticeable) will be administered once daily for at least 5 days, in addition to standard rehabilitation.
In the sham stimulation group, sensory-level electrical stimulation will be administered as sham therapy in addition to standard rehabilitation.

Outcome(s)

• Primary Outcome: Skeletal muscle cross-sectional area and intramuscular adipose tissue assessed by computed tomography.
• Secondary Outcome: Muscle thickness and muscle echo intensity by ultrasound device.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients under 18 years of age. 2.Patients for whom measurements are difficult to perform. 3.Patients diagnosed with brainstem or cerebellar infarction or hemorrhage without unilateral motor paralysis. 4.Patients with motor paralysis in all four limbs. 5.Patients who were unable to get out of bed within the first week of hospitalization. Those who meet any of the above five criteria will be excluded from the study.

Related Information

• Primary Sponsor: Gifu Prefectural Tajimi Hospital
• Source(s) of Monetary Support: None