Change in Pulse Wave Characteristics of the Radial Artery during the Treatment for Ischemic Stroke Patients with Hemiplegia: Exploratory, Prospective Study
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002147
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 86
(1) Male and female adult patients aged between 45 and 74 years old.
(2) Patients with lateral movement disorders who can walk, selected from among those with ischemic stroke diagnosed by computed tomography. (CT) or magnetic resonance imaging (MRI) scans for the first time.
(3) Patients who had experienced a stroke within six months.
(4) Patients who had required hospital treatment to treat ischemic stroke.
(5) Patients whose score for manual muscle testing (MMT) was four or less.
(6) Patients who had scores of 24 or more in the Mini Mental Stated Examination-Korean version (MMSE-K) and no cognitive functional disability.
(7) Patients who understood and were willing to comply with all test procedures, with voluntary participation in the clinical study.
(8) Patients who signed and submitted a consent form for participation in the clinical study.
(1) Persons diagnosed with hemorrhagic stroke through CT or MRI scans.
(2) Persons whose pulse waves were not easily measured due to malformation of blood vessels around the wrist or bone fractures, or patients who cannot could not comply with the test procedure due to other reasons.
(3) Persons who had serious organic diseases (cardiac disorder, lung disease, liver, or kidney diseases) or history of a central nervous system or psychiatric disorder or taking psychoactive drugs.
(4) Persons with neurological disorders other than strokes.
(5) SBP < 90 mmHg or SBP > 220 mmHg, DBP < 40 mmHg or DBP > 130 mmHg.
(6) Persons with musculoskeletal diseases or rheumatic diseases.
(7) Pregnant or nursing women.
(8) Persons with implanted cardiac pacemakers and electronic device.
(9) Persons who had a skin trouble around the electrode attachment region or side effects during electrode attachment.
(10) Persons who could not comply with the stroke clinical pathway (CP) provided by the treatment institution.
(11) Persons with unstable heartbeat.
(12) Persons with a history of drug or alcohol abuse.
(13) Persons who had participated in other clinical tests in the recent three months.
(14) Persons who had an abnormal reaction to traditional Korean medicine or acupuncture.
(15) Persons who were viewed as inappropriate for the clinical study by the research head or staff.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method radial augmentation index (rAIx)
- Secondary Outcome Measures
Name Time Method spectral energy (SE);pulse power index (PPI);respiration (RSP);heart rate variability (HRV);Brachial Ankle Pulse Wave Velocity (BaPWV);Ankle-Brachial Index (ABI);Palm skin temperature;soft lean mass (SLM), total body water (TBW), body fat mass(BFM);walking ability assessment;high sensitivity C-reactive protein (hs-CRP);thrombus-related index - vWF/D-dimer/fibrinogen;Relative Viscosity (RV);Manual Muscle Testing (MMT);Mini Mental Stated Examination-Korean Version (K-NIHSS);Beck Depression Inventory (BDI);Blood Stasis Questionnaire (BSQ)