Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A Functional Near-infrared Spectroscopy (fNIRs) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The neuromuscular activity of the EMG feedback-based standing training
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The neuromuscular activity of the EMG feedback-based standing training
Time Frame: 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
Time Frame: 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
Time Frame: 1 day
Comparison of the differences in brain activation \[HbO2 (mmol/L\*mm）\] during the sit-to-stand process in the two models.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dingqun Bai
Director, Department of rehabilitation medicine, Principal Investigator, Clinical Professor
First Affiliated Hospital of Chongqing Medical University