Neural Changes in Stroke Patients During Challenging Walking Tasks.

January 1, 2025 updated by: Zhao Jing, Nanjing Medical University

Neural Mechanism Changes in Stroke Patients During Challenging Environments

For stroke patients, a challenging, unfamiliar, and more difficult task may increase the likelihood of brain activation to stimulate recovery. Pedal walking and walking with eyes-covered are both difficult and challenging tasks for stroke patients. The investigators intend to study the biomechanics and neural mechanisms of challenging pedal walking and walking with eyes covered.

Stroke participants will wear electroencephalogram electrode caps and perform three tasks: walking on a flat surface for 60 seconds, walking on pedal for 60 seconds, and walking with eyes covered for 60 seconds.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke participants will wear a 32-lead electroencephalogram electrode cap (Zhentai Technology Company, Xi 'an, China), first walk on a flat ground for 60 seconds, rest for 2 minutes, then walk on the pedal for 60 seconds, rest again for 2 minutes, and walk for 60 seconds with eyes-covered.

Study Type

Observational

Enrollment (Estimated)

60

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Geriatric Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Geriatric Hospital of Nanjing Medical University, 269 Qingmen Street

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

No

Sampling Method

Probability Sample

Study Population

Stroke patients, including outpatients and inpatients.

Description

Inclusion Criteria:

  • First-time occurrence of stroke confirmed by computed tomography or magnetic resonance imagingClinical diagnosis of stroke
  • Disease duration of more than 14 days， less than 1 year
  • Able to walk independently but with a lingering abnormal gait

Exclusion Criteria:

  • Lesions accumulate in the brainstem
  • Lesions accumulate in the cerebellum
  • Impaired vision
  • Severe cognitive impairment

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
Intervention / Treatment
stroke participants
Stroke participants with residual abnormal gait.
Other: pedal walking
Pedal walking is a challenging walking task that can be used as a form of physical therapy for stroke participants.
Other: visual occlusion
Walking with eyes-covered is a challenging walking task that can be used as a form of physical therapy for stroke participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Phase Lag Index
Time Frame: The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds
The Weighted Phase Lag Index (WPLI) is a measure used to quantify phase synchronization in electrophysiological data.Continuously measure the connectivity of the coupling of neural oscillatory activity in the brain, while being statistically more powerful in detecting changes in signal phase synchronization.The WPLI ranges from 0 to 1, with 0 indicating no phase synchronization and 1 indicating complete phase synchronization.
The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds
Relative power
Time Frame: The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds
The electroencephalogram signal in the time domain is converted into the relevant information in the frequency domain, the frequency bands are divided, and the relative power results of each channel in each frequency band are derived. Among them, delta:1-4Hz, theta:4-8Hz, alpha:8-15Hz, beta:15-30Hz, gamma:30-45Hz.
The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds

Collaborators and Investigators

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

Sponsor

Nanjing Medical University

Investigators

  • Study Director: Xia Li Zhang, doctor, Geriatric Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 1, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024018-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication.

IPD Sharing Time Frame

Six months after publication.

IPD Sharing Access Criteria

Request from the corresponding author by email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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