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

NCT06062407 | Unknown

• 1 other identifier: 2023-810
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (1)

• Yang Z, Ye L, Yang L, Lu Q, Yu A, Bai D. Early screening of post-stroke fall risk: A simultaneous multimodal fNIRs-EMG study. CNS Neurosci Ther. 2024 Sep;30(9):e70041. doi: 10.1111/cns.70041.

  PMID: 39315509 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dingqun Bai

  The Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Zheng Yang

CONTACT

023-89011334; 2022140041@stu.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of rehabilitation medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 2, 2023
• Study Start: August 10, 2023
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CN (1)