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

September 28, 2023 updated by: Dingqun Bai, First Affiliated Hospital of Chongqing Medical University

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Chongqing, China
        • Recruiting
        • Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stroke subjects without fall risk
The patient was diagnosed with a stroke with a berg score of not less than 40.
Stroke subjects with fall risk
The patient was diagnosed with a stroke with a berg score of less than 40.
Healthy subjects
No history of stroke with normal lower limb motor function and balance

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
Comparison of differences in brain activation [HbO2 (mmol/L*mm)] between post-stroke patients with fall risk and healthy subjects
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Dingqun Bai, The Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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