- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062407
Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A fNIRs Study
Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A Functional Near-infrared Spectroscopy (fNIRs) Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zheng Yang
- Phone Number: 023-89011334
- Email: 2022140041@stu.cqmu.edu.cn
Study Locations
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Chongqing, China
- Recruiting
- Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University
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Contact:
- Zheng Yang
- Email: 2022140041@stu.cqmu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients with stroke in the inpatient ward of the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.
Healthy subjects recruited through the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.
Description
Inclusion Criteria:
Stroke patients 1. Diagnosis of stroke confirmed by neuroimaging (CT or MRI) evaluation 2. 18-85 years old 3. Able to complete the sit-to-stand transition 4. Able to follow instructions to complete the trial 5. Patients who signed an informed consent form.
Healthy Subjects: 1. No abnormalities on cranial fMRI examination 2. 18-85 years old 3. Able to complete the sit-to-stand transition 4. Able to follow instructions to complete the trial 5. not taking medications. 6. Subjects who signed an informed consent form
Exclusion Criteria:
Stroke patients: 1. Inability to tolerate the test due to organic diseases 2. Serious mental illness that prevents them from cooperating with or tolerating the trial 3. Pregnant or lactating women 4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.
Healthy Subjects: 1. Inability to tolerate the test due to organic diseases 2. Serious mental illness that prevents them from cooperating with or tolerating the trial. 3. Pregnant or lactating women 4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stroke subjects without fall risk
The patient was diagnosed with a stroke with a berg score of not less than 40.
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Stroke subjects with fall risk
The patient was diagnosed with a stroke with a berg score of less than 40.
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Healthy subjects
No history of stroke with normal lower limb motor function and balance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preliminary screening of brain function biomarkers for fall risk in post-stroke patients
Time Frame: 1 day
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Comparison of differences in brain activation [HbO2 (mmol/L*mm)] between post-stroke patients with fall risk and healthy subjects
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1 day
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The brain functional effectiveness of the EMG feedback-based standing training
Time Frame: 1 day
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Comparison of the differences in brain activation [HbO2 (mmol/L*mm)] during the sit-to-stand process in the two models.
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1 day
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The neuromuscular activity of the EMG feedback-based standing training
Time Frame: 1 day
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Comparison of the differences in electromyographic changes [EMG (uv)] during the sit-to-stand process in the two models.
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1 day
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Collaborators and Investigators
Investigators
- Study Chair: Dingqun Bai, The Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-810
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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