A Study on the Characterization of Fatigue Patients after Stroke
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003900
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
(1) men or women who are not pregnant or are not breastfed at the age of 19-80 years
(2) Patients diagnosed with cerebral hemorrhage or cerebral infarction via brain computed tomography or magnetic resonance imaging (MRI)
(3) No conscious impairment (Mental Grade I)
(4) Subjects who voluntarily agreed to participate in this trial
If there are any of the following items, they should be excluded from this study.
(1) Subejcts who diagnosed with degenerative brain disease (eg, Parkinson's disease, Alzheimer's disease)
(2) Patients diagnosed with subarachnoid hemorrhage via brain computed tomography or magnetic resonance imaging (MRI)
(3) Patients who have other brain diseases (eg, brain tumor, traumatic brain injury, arteriovenous malformation, moyamoya disease, stroke due to these diseases, etc.)
(4) Disabled patients who have already suffered from other neurological and muscular disorders
(5) Patients with unstable vital signs during screening (eg, systolic blood pressure of 160 mmHg or more even when taking medications)
(6) Patient with severe illness (eg, cancer, liver disease, kidney disease, severe heart failure (NYHA class III or higher), etc.)
(7) Patients who participated in other clinical trials within 30 days
(8) If the evaluator finds it inappropriate to participate in the screening for other reasons
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of autonomic nervous system function (Heart rate variability (HRV), 24-hour ambulatory blood pressure (24ABPM))
- Secondary Outcome Measures
Name Time Method Assessment of microcirculation, arteriosclerosis (nailfold capillaroscopy, nail compression test, Cardio-ankle vascular index (CAVI), Ankle-brachial pressure index (ABI), Acceleration pulse wave test);Assessment of depression tendency (Patient Health Questionnaire-9 (PHQ-9), Beck Depression Inventory (BDI));Assessment of cognitive function (Mini-Mental State Examination-Korean (MMSE-K), Clinical Dementai Rating (CDR));Assessement of neurological deficit (Fugl-Meyer Assessment score [Upper limb/Lower limb], National Institute of Health Stroke Scale (NIHSS));Assessement of impact of fatigue (modified Barthel Index (mBI), Modified Fatigue Impact Scale, Stroke Specific Quality of Life (SS-QOL))