Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06401837). This is a study registration, not published results. Lead sponsor: China Medical University Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 52 participants (ACTUAL). Conditions: Inflammatory Cytokine, Circadian Rhythm, Acupressure, Post-stroke Fatigue, Sleep, Ischemic Stroke. Interventions: BEHAVIORAL: Circadian based acupressure application. Primary outcome measures: Inflammatory cytokines , 10 cc of urine sample in the morning will be collected from each patient at baseline, and after 2 weeks of intervention.; Sleep , Patients wear a consumer tracker at baseline, 1st week during intervention, and after 2nd weeks of intervention for 24 hours each.; Sleep quality , Patients will fill out the PSQI questionnaire at baseline, 1st week during intervention, and after 2nd weeks of intervention.; Fatigue. , Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.. Brief summary: Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25\~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to (1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards. Patients with fatigue (FAS\>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.