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NCT Number: NCT06395142

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pedal walking

Other

Pedal walking is a challenging task for stroke participants and can be used as a means of stroke rehabilitation. A cross-sectional study is conducted to investigate the real-time changes in plantar pressure and electroencephalogram during pedal walking in stroke participants.

visual-deprivation walking

Other

visual-deprivation walking is a challenging task for stroke participants and can be used as a means of stroke rehabilitation.A cross-sectional study is conducted to investigate the real-time changes in plantar pressure and electroencephalogram during visual-deprivation walking in stroke participants.

Primary outcomes

  1. phase-amplitude coupling

    Time frame: 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.

  2. phase-frequency coupling

    Time frame: 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.

  3. phase-phase coupling

    Time frame: 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.

  4. Amplitude-amplitude coupling

    Time frame: 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 .

  5. relative power

    Time frame: 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.

  6. weight Phase Lag Index

    Time frame: 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.

  7. peak pressure

    Time frame: Through study completion, an average of 2 months.

    Peak pressure reflects the maximum pressure on the entire sole of the foot.

Sponsors and collaborators

Lead sponsor

Geriatric Hospital of Nanjing Medical University

Other

Registry information

Official study title

Changes of Plantar Pressure and Electroencephalographic Signals During Pedal Walking and Vision-deprivation Walking in Stroke Patients.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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