Plantar Pressure and Electroencephalographic Signals During Pedal and Vision-deprived Walking in Stroke Patients.

Completed

• Conditions: Stroke
• Interventions: Other: pedal walking; Other: visual-deprivation walking

• Registration Number: NCT06395142
• Lead Sponsor: Geriatric Hospital of Nanjing Medical University

Brief Summary

Complex task training may be more effective than simple task training in promoting functional recovery and brain restructuring in stroke participants. The researchers intend to investigate the real-time changes in plantar pressure and electroencephalographic signals in stroke participants during two complex tasks: pedal walking and visual-deprivation walking. The research hypothesis is that pedal walking and visual-deprivation walking can improve the difference of plantar pressure between the affected and unaffected lower limbs of stroke participants, and cause corresponding electroencephalographic changes.

Detailed Description

Stroke participants perform the following tasks after wearing a plantar pressure device and a 32-lead electroencephalographic cap. First, stroke participants walk on the pedal on the lower limbs of the affected side. Then the researchers cover the participants' eyes with an eye mask, the participants perform the task of visual-deprivation walking. Finally, the participants walk on a flat surface. Each walking task lasts for 60 seconds. The participants can rest for 3-5 minutes between tasks.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-28
• Study First Posted: 2024-05-02
• Status Verified: 2024-06
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• MRI or CT diagnosis of the first stroke onset；
• The onset of the stroke occurred more than 30 days;
• Safely walk 50 meters without assistance.

Exclusion Criteria

• Cerebellar injury；
• Brain stem injury；
• Visual impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stroke participants	pedal walking	Stroke participants performe pedal walking and visual-deprivation walking successively.
stroke participants	visual-deprivation walking	Stroke participants performe pedal walking and visual-deprivation walking successively.

Primary Outcome Measures

Name	Time	Method
phase-amplitude coupling	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	Phase-amplitude coupling is a type of cross-phase coupling that represents the coupling between the phase of slow oscillations and the amplitude of fast oscillations.
phase-phase coupling	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	Phase-phase coupling is a special form of cross-phase coupling that represents the coupling between the phases of slow and fast oscillations, which can occur even when the coupling is very weak.
Amplitude-amplitude coupling	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	Amplitude-amplitude coupling is a form of cross-phase coupling that represents the coupling between the amplitudes of slow oscillations and fast oscillations .
weight Phase Lag Index	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	The weight phase lag index is an index of brain functional connectivity, can continuously measure the connectivity of the coupling of neural oscillatory activity.
relative power	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	Relative power reflects the frequency domain changes of electroencephalogram.
peak pressure	Through study completion, an average of 2 months.	Peak pressure reflects the maximum pressure on the entire sole of the foot.
phase-frequency coupling	Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.	Phase-frequency coupling is a generic form of the cross-frequency coupling model, representing the coupling between the slow oscillations phase and the fast oscillations frequency.

Trial Locations

Locations (1)

Geriatric Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China