Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A Functional Near-infrared Spectroscopy (fNIRs) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The neuromuscular activity of the EMG feedback-based standing training
研究概览
简要总结
This is a functional near infrared spectroscopy (fNIRs) study designed to screen for risk of falls after diagnosis of stroke and initial intervention.
详细描述
This was an initial screening and preliminary intervention study. Each subject underwent two models of simultaneous fNIRs-EEG testing during the sit-to-stand process, the first without any intervention and the second based on biofeedback (EMG feedback) during the sit-to-stand process. Initial screening of fall risk in post-stroke patients was performed by comparing differences in brain activation and brain network connectivity between patients and healthy subjects. Preliminary validation the effectiveness of the EMG feedback-based sitting and standing training for post-stroke patients by comparing the differences of brain activation, brain network connectivity, and electromyographic changes during the sit-to-stand process in the two models.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stroke patients
- •Diagnosis of stroke confirmed by neuroimaging (CT or MRI) evaluation
- •18-85 years old
- •Able to complete the sit-to-stand transition
- •Able to follow instructions to complete the trial
- •Patients who signed an informed consent form.
- •Healthy Subjects:
- •No abnormalities on cranial fMRI examination
- •18-85 years old
- •Able to complete the sit-to-stand transition
- •Able to follow instructions to complete the trial
- •not taking medications.
- •Subjects who signed an informed consent form
排除标准
- •Stroke patients:
- •Inability to tolerate the test due to organic diseases
- •Serious mental illness that prevents them from cooperating with or tolerating the trial
- •Pregnant or lactating women
- •Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.
- •Healthy Subjects:
- •Inability to tolerate the test due to organic diseases
- •Serious mental illness that prevents them from cooperating with or tolerating the trial.
- •Pregnant or lactating women
- •Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction
结局指标
主要结局
The neuromuscular activity of the EMG feedback-based standing training
时间窗: 1 day
Comparison of the differences in electromyographic changes \[EMG (uv)\] during the sit-to-stand process in the two models.
Preliminary screening of brain function biomarkers for fall risk in post-stroke patients
时间窗: 1 day
Comparison of differences in brain activation \[HbO2 (mmol/L\*mm)\] between post-stroke patients with fall risk and healthy subjects
The brain functional effectiveness of the EMG feedback-based standing training
时间窗: 1 day
Comparison of the differences in brain activation \[HbO2 (mmol/L\*mm）\] during the sit-to-stand process in the two models.
次要结局
未报告次要终点
研究者
Dingqun Bai
Director, Department of rehabilitation medicine, Principal Investigator, Clinical Professor
First Affiliated Hospital of Chongqing Medical University