NCT06395142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

April 24, 2024

Last Update Submit

June 30, 2024

Conditions

Keywords

Electroencephalographypedal walkingvisual deprivationchallenging task

Outcome Measures

Primary Outcomes (7)

  • phase-amplitude coupling

    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.

    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

    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.

    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

    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.

    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

    Amplitude-amplitude coupling is a form of cross-phase coupling that represents the coupling between the amplitudes of slow oscillations and fast oscillations .

    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

    Relative power reflects the frequency domain changes of electroencephalogram.

    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.

  • weight Phase Lag Index

    The weight phase lag index is an index of brain functional connectivity, can continuously measure the connectivity of the coupling of neural oscillatory activity.

    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.

  • peak pressure

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

    Through study completion, an average of 2 months.

Study Arms (1)

stroke participants

Stroke participants performe pedal walking and visual-deprivation walking successively.

Other: pedal walkingOther: visual-deprivation walking

Interventions

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.

stroke participants

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.

stroke participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke participants recruited from inpatient and outpatient departments of tertiary hospitals.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (3)

  • Oliveira AS, Schlink BR, Hairston WD, Konig P, Ferris DP. Restricted vision increases sensorimotor cortex involvement in human walking. J Neurophysiol. 2017 Oct 1;118(4):1943-1951. doi: 10.1152/jn.00926.2016. Epub 2017 Jul 5.

    PMID: 28679843BACKGROUND
  • Fettrow T, Hupfeld K, Tays G, Clark DJ, Reuter-Lorenz PA, Seidler RD. Brain activity during walking in older adults: Implications for compensatory versus dysfunctional accounts. Neurobiol Aging. 2021 Sep;105:349-364. doi: 10.1016/j.neurobiolaging.2021.05.015. Epub 2021 May 31.

    PMID: 34182403BACKGROUND
  • Krakauer JW. Motor learning: its relevance to stroke recovery and neurorehabilitation. Curr Opin Neurol. 2006 Feb;19(1):84-90. doi: 10.1097/01.wco.0000200544.29915.cc.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xia Li Zhang, doctor

    Geriatric Hospital of Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 2, 2024

Study Start

August 1, 2023

Primary Completion

June 15, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations