Actively Recruiting

Phase Not Applicable
Age: 50Years - 95Years
All Genders
NCT06401837

Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients

Led by China Medical University Hospital · Updated on 2024-05-07

78

Participants Needed

2

Research Sites

98 weeks

Total Duration

On this page

Sponsors

C

China Medical University Hospital

Lead Sponsor

N

National Science and Technology Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients

Who Can Participate

Age: 50Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years and older, any gender
  • Diagnosed with ischemic stroke
  • Clear consciousness with Glasgow Coma Scale score of 13 or higher
  • Stable vital signs and neurological status with no or controlled complications like infection or gastrointestinal bleeding
  • Experiencing fatigue with Fatigue Assessment Scale score 24 or above
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment preventing consent
  • Difficulty speaking (dysphasia)
  • Use of ventilation
  • Multiple unstable diseases
  • Currently receiving acupuncture therapy on the same acupoints

AI-Screening

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Trial Site Locations

Total: 2 locations

1

China Medical University Hospital Taichung East Branch

Taichung, Taiwan, 401005

Actively Recruiting

2

China Medical University Hospital

Taichung, Taiwan, 40447

Actively Recruiting

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Research Team

W

Wen-Chun Liao, PhD

CONTACT

L

Li-Wei Chou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients | DecenTrialz