Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients: a Randomized, Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Uric acid levels
研究概览
简要总结
Introduction and Purpose:
Patients with stroke have over a decade of experience with vascular laser treatment. Previous studies predominantly used low-energy vascular lasers with red light, specifically helium-neon lasers with a wavelength of 632.8nm. However, different colored lights are absorbed by cells in the body in varying proportions, leading to potentially different effects. Therefore, there is an interest in understanding the impact of other colored lights on stroke patients. To understand the practical effects of low-energy laser treatment with different colored lights on improving neurological function and controlling recurrent stroke risk factors.
Methods:
A randomized crossover trial will be conducted with a study population consisting of individuals aged 20 and above who have experienced their first stroke within the last 6 months. Exclusion criteria include patients with skin conditions unsuitable for injection or light exposure, those with light allergies, pregnant individuals, those with abnormal blood clotting function, those with implanted pacemakers, and individuals unable to comply with the 5-month study plan. Participants will undergo 10 sessions of infrared light and 10 sessions of blue light vascular laser treatment. Blood tests and neurological assessments will be conducted before each treatment session (10 irradiations) and at the end of the two-month washout period between the two different colored lights. Descriptive analysis and pair t-tests will be employed to compare baseline values between the two groups. Subsequently, repeated measures ANOVA will be used to analyze differences between the intervention group and the control group. The study will examine whether various influencing factors are associated with receiving vascular laser treatment with different colored lights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as a first-time stroke patient.
- •Onset of illness within 6 months of enrollment.
- •Recruitment period from January to December of the year
- •All participants or their legal representatives must sign the informed consent form.
排除标准
- •Skin diseases that make injection or photosensitivity unsuitable.
- •Pregnancy and abnormal blood clotting function.
- •Presence of a cardiac pacemaker.
- •Inability to comply with the 5-month study plan.
研究组 & 干预措施
Red-Blue Arm
Participants in this arm first receive 10 sessions of vascular laser treatment with red light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with blue light.
干预措施: Intravenous Laser Irradiation of Blood (Device)
Blue-Red Arm
Participants in this arm first receive 10 sessions of vascular laser treatment with blue light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with red light.
干预措施: Intravenous Laser Irradiation of Blood (Device)
结局指标
主要结局
Uric acid levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Uric acid levels are typically 2.5-7.0 milligrams per deciliter (mg/dL) in males and 1.5-6.0 mg/dL in females. Low levels are rare, but high levels can lead to gout, kidney disease, and other health issues.
Barthel Index and IADL (Instrumental Activities of Daily Living) Scores
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Assesses a person's ability to perform basic activities of daily living (ADL), such as bathing, dressing, and feeding. Instrumental Activities of Daily Living extends the assessment to more complex activities, including managing finances and using transportation.
Creatinine test
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Measure of how well your kidneys are performing their job of filtering waste from your blood.
Blood triglycerides
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Low-Density Lipoprotein levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Hemoglobin A1c levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood glucose control
Blood Prothrombin Time
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood coagulation function control
Activated Partial Thromboplastin Time levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood coagulation function control
Modified Rankin Scale (MRS)
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Modified Rankin Scale is a scale that measures the degree of disability or dependence in daily activities following a neurological event, such as a stroke.
Blood urea nitrogen (BUN) test
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Can reveal whether your urea nitrogen levels are higher than normal, suggesting that your kidneys may not be working properly.
Blood cholesterol
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Blood Glucose after meal
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood glucose control
Blood Interleukin-6 levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
High-sensitivity C-reactive Protein levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
MMSE (Mini-Mental State Examination) Score
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
MMSE is a widely used screening tool for cognitive impairment. It evaluates various cognitive functions, including orientation, memory, and language. Changes in MMSE scores may indicate alterations in cognitive abilities, providing insights into the impact of interventions on cognitive function.
Berg Balance Test Score
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Berg Balance Test assesses a person's balance and risk of falling. It includes tasks such as standing on one foot and turning around. Changes in Berg Balance Test scores can indicate improvements or declines in balance and stability.
High-Density Lipoprotein levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Complete Blood Count test
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood cell ratio control
Blood Tumor Necrosis Factor-alpha levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
Erythrocyte Sedimentation Rate levels
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
Fugl-Meyer Assessment Score
时间窗: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Fugl-Meyer Assessment is commonly used to evaluate motor recovery after stroke. It assesses motor function, balance, and sensation. Changes in Fugl-Meyer scores can indicate improvements or declines in motor function and overall recovery.
次要结局
未报告次要终点