StrokeNCT06840405
Cortical Activation During Walking in Stroke
An observational study of Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
After stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. The affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2025to 28 Feb 2028
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with chronic stroke
Who may be able to join
- ≥ 6 months after the diagnosis of stroke
- Independent walking over at least 7m with or without a walking aid
- Mini-mental state examination score ≥ 24
Who cannot join
- Had difficulty in backward walking
- Any neuromuscular disorders history
- With visual or auditory disorders
- Unstable cardiac status or uncontrolled hypertension
- Any musculoskeletal disorders that would affect walking ability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-2826-7279, yryang@nycu.edu.tw
About this study
Official title: Cortical Activation During Forward and Backward Walking in Individuals With Chronic Stroke
After stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. The affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. This phenomenon, referred to as interhemispheric imbalance, further inhibits activity in the affected hemisphere, thereby restricting motor recovery. According to the interhemispheric competition model, enhancing excitability in the affected hemisphere and/or suppressing excitability in the unaffected hemisphere may contribute to the improvement of motor function in individuals with stroke. Furthermore, as motor function recovers, the balance of interhemispheric activation in motor-related cortical areas undergoes corresponding changes. Previous studies have shown that treadmill training enhances the excitability of the primary motor cortex in both hemispheres of stroke patients, as well as increases excitability across multiple cortical and subcortical regions in both hemispheres. However, it remains unclear whether treadmill training can normalize the interhemispheric imbalance in stroke patients. Additionally, the effects of forward and backward walking on the activity of motor-related brain regions in individuals with stroke are still unclear. Therefore, this cross-sectional study aims to investigate the changes in motor-related brain activity during forward walking and backward walking in individuals with chronic stroke.
- Conditions
- Stroke
- Keywords
- Forward walking, Backward walking, Brain activity, Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.
Measured: One-time measurement during a one-minute walking task at a single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start24 Apr 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840405
- Sponsor's protocol ID
- NYCU113210AF1
- Status last verified
- Jun 2025
- First submitted
- 17 Feb 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Activation During Forward and Backward Walking in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06840405
- Acronym / sponsor ID
- NYCU113210AF1
- Conditions
- Stroke
- Keywords
- Forward walking, Backward walking, Brain activity, Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 21 Feb 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.
After stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. The affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. This phenomenon, referred to as interhemispheric imbalance, further inhibits activity in the affected hemisphere, thereby restricting motor recovery. According to the interhemispheric competition model, enhancing excitability in the affected hemisphere and/or suppressing excitability in the unaffected hemisphere may contribute to the improvement of motor function in individuals with stroke. Furthermore, as motor function recovers, the balance of interhemispheric activation in motor-related cortical areas undergoes corresponding changes. Previous studies have shown that treadmill training enhances the excitability of the primary motor cortex in both hemispheres of stroke patients, as well as increases excitability across multiple cortical and subcortical regions in both hemispheres. However, it remains unclear whether treadmill training can normalize the interhemispheric imbalance in stroke patients. Additionally, the effects of forward and backward walking on the activity of motor-related brain regions in individuals with stroke are still unclear. Therefore, this cross-sectional study aims to investigate the changes in motor-related brain activity during forward walking and backward walking in individuals with chronic stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with chronic stroke
Key inclusion criteria (3 listed)
- ≥ 6 months after the diagnosis of stroke
- Independent walking over at least 7m with or without a walking aid
- Mini-mental state examination score ≥ 24
Key exclusion criteria (5 listed)
- Had difficulty in backward walking
- Any neuromuscular disorders history
- With visual or auditory disorders
- Unstable cardiac status or uncontrolled hypertension
- Any musculoskeletal disorders that would affect walking ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity
Time frame: One-time measurement during a one-minute walking task at a single study visit
Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.
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 12 Jun 2025.
- 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.
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 National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 5 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 12 Jun 2025. 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 Taiwan. 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 Yea-Ru Yang, PhD (+886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: One-time measurement during a one-minute walking task at a single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2025.