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

Recruiting

• Conditions: Stroke

• Registration Number: NCT06062407
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-08-10
• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Primary Completion: 2023-10
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The neuromuscular activity of the EMG feedback-based standing training	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	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	1 day	Comparison of the differences in brain activation \[HbO2 (mmol/L\*mm）\] during the sit-to-stand process in the two models.

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China