Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A fNIRs Study

Stroke Clinical Trial

Official title:

Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A Functional Near-infrared Spectroscopy (fNIRs) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062407
• Other study ID #: 2023-810
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Zheng Yang
• Phone: 023-89011334
• Email: 2022140041[@]stu.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a functional near infrared spectroscopy (fNIRs) study designed to screen for risk of falls after diagnosis of stroke and initial intervention.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
China	Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary screening of brain function biomarkers for fall risk in post-stroke patients	Comparison of differences in brain activation [HbO2 (mmol/L*mm)] between post-stroke patients with fall risk and healthy subjects	1 day
Primary	The brain functional effectiveness of the EMG feedback-based standing training	Comparison of the differences in brain activation [HbO2 (mmol/L*mm)] during the sit-to-stand process in the two models.	1 day
Primary	The neuromuscular activity of the EMG feedback-based standing training	Comparison of the differences in electromyographic changes [EMG (uv)] during the sit-to-stand process in the two models.	1 day