StrokeNCT06764290
Neural Changes in Stroke Patients During Challenging Walking Tasks.
An observational study of Stroke, run by Nanjing Medical University at 2 sites in China.
Trial summary
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. 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 occlusion
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patients, including outpatients and inpatients.
Who may be able to join
- 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
Who cannot join
- Lesions accumulate in the brainstem
- Lesions accumulate in the cerebellum
- Impaired vision
- Severe cognitive impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Geriatric Hospital of Nanjing Medical University, 269 Qingmen Street
Nanjing, Jiangsu, 210000
- Recruiting
Geriatric Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qian Zhang, Phd, +86 181 68417672, 2317123547@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- pedal walking, visual occlusion
- Keywords
- Electroencephalography, gait rehablitation, 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 walking task that can be used as a form of physical therapy for stroke participants.
visual occlusionOther
Walking with eyes-covered is a challenging walking task that can be used as a form of physical therapy for stroke participants.
| Study group | Role | What they receive |
|---|---|---|
| stroke participants | Stroke participants with residual abnormal gait. Receives: Other: pedal walking; Other: visual occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Phase Lag Index
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Apr 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Jing, Nanjing Medical University
- Investigators
- Xia Li Zhang, doctor, Study director, Geriatric Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764290
- Sponsor's protocol ID
- 2024018-1
- Status last verified
- Jan 2025
- First submitted
- 10 Apr 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Publications
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.
PubMed 16415682Fettrow 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 34182403Kulkarni A, Cui C, Rietdyk S, Ambike S. Humans prioritize walking efficiency or walking stability based on environmental risk. PLoS One. 2023 Apr 7;18(4):e0284278. doi: 10.1371/journal.pone.0284278. eCollection 2023.
PubMed 37027387
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanism Changes in Stroke Patients During Challenging Environments
- ClinicalTrials.gov ID
- NCT06764290
- Acronym / sponsor ID
- 2024018-1
- Conditions
- Stroke
- Keywords
- Electroencephalography, gait rehablitation, challenging task
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke participants | – | Other: pedal walking, Other: visual occlusionStroke participants with residual abnormal gait. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients, including outpatients and inpatients.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Lesions accumulate in the brainstem
- Lesions accumulate in the cerebellum
- Impaired vision
- Severe cognitive 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 walking task that can be used as a form of physical therapy for stroke participants. | Other | stroke participants |
| visual occlusionWalking with eyes-covered is a challenging walking task that can be used as a form of physical therapy for stroke participants. | Other | stroke participants |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Background: 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.
- 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.
- Background: PubMed 37027387Kulkarni A, Cui C, Rietdyk S, Ambike S. Humans prioritize walking efficiency or walking stability based on environmental risk. PLoS One. 2023 Apr 7;18(4):e0284278. doi: 10.1371/journal.pone.0284278. eCollection 2023.
- This paper suggests that the rehabilitation of stroke patients may require more challenging tasksLink provided by the sponsor.
- This paper suggests that the performance of complex walking tasks may involve top-down cortical control in the brain centersLink provided by the sponsor.
- This paper shows that the central nervous system will actively respond to environmental changes and adjust to obtain stable motor outputLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Xia Li Zhang, doctor study director
Geriatric Hospital of Nanjing Medical University
2 sites 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 Nanjing Medical University at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhao, master (+8618817892579, 18817892579@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 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 NCT06764290, which also lists 3 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 8 Jan 2025.