StrokeNCT06395142
Plantar Pressure and Electroencephalographic Signals During Pedal and Vision-deprived Walking in Stroke Patients.
An observational study of Stroke, run by Geriatric Hospital of Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- pedal walking and visual-deprivation walking
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke participants recruited from inpatient and outpatient departments of tertiary hospitals.
Who may be able to join
- 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.
Who cannot join
- Cerebellar injury；
- Brain stem injury；
- Visual impairment.
Trial locations and contacts
1 site in 1 country.
China1 site
Geriatric Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: Changes of Plantar Pressure and Electroencephalographic Signals During Pedal Walking and Vision-deprivation 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- pedal walking, visual-deprivation walking
- Keywords
- Electroencephalography, pedal walking, visual deprivation, challenging task
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedal walkingOther
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 walkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| stroke participants | Stroke participants performe pedal walking and visual-deprivation walking successively. Receives: Other: pedal walking; Other: visual-deprivation walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Aug 2023
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatric Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Zhao, Geriatric Hospital of Nanjing Medical University
- Investigators
- Xia Li Zhang, doctor, Study chair, Geriatric Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395142
- Sponsor's protocol ID
- LL2024018-1
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28679843Fettrow 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.
PubMed 34182403Krakauer 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.
PubMed 16415682Zhao J, Zhuang X, Wang H, Xu H, Zhang Q, Zhang L. Brain adaptations in challenging walking task of people with stroke: an experimental study. J Neuroeng Rehabil. 2026 Mar 27;23(1):150. doi: 10.1186/s12984-026-01951-6.
PubMed 41896914
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Plantar Pressure and Electroencephalographic Signals During Pedal Walking and Vision-deprivation Walking in Stroke Patients.
- ClinicalTrials.gov ID
- NCT06395142
- Acronym / sponsor ID
- LL2024018-1
- Conditions
- Stroke
- Keywords
- Electroencephalography, pedal walking, visual deprivation, challenging task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Geriatric Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke participants | – | Other: pedal walking, Other: visual-deprivation walkingStroke participants performe pedal walking and visual-deprivation walking successively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke participants recruited from inpatient and outpatient departments of tertiary hospitals.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Cerebellar injury；
- Brain stem injury；
- Visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedal walkingPedal 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. | Other | stroke participants |
| visual-deprivation walkingvisual-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. | Other | stroke participants |
Primary outcome
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.
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.
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.
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 .
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 28679843Oliveira 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.
- Background: PubMed 34182403Fettrow 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.
- Results publication: PubMed 16415682Krakauer 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.
- Derived from this study: PubMed 41896914Zhao J, Zhuang X, Wang H, Xu H, Zhang Q, Zhang L. Brain adaptations in challenging walking task of people with stroke: an experimental study. J Neuroeng Rehabil. 2026 Mar 27;23(1):150. doi: 10.1186/s12984-026-01951-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Li Zhang, doctor study chair
Geriatric Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Geriatric Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395142, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.