StrokeNCT06187467
Longitudinal Multimodal Profiling of Balance and Gait In Stroke
An observational study of Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. Researchers have effectively utilized EEG to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (BCI) motor profiling. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Clinical and technological-aided assessments and questionnaires
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2024to 20 Jun 2025
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in outpatient clinics
Who may be able to join
- First-ever clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors brain imaging
- Age 21 to 85 years
- At least ≥ 30 days post-stroke
- Gait impairments related to stroke
- Functional ambulation category -6 levels (Mehrholz et al, 2007): FAC ≥ 4, i.e. able to ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, non-level surfaces).
- Montreal Cognitive Assessment (MoCA) score > 21 (Nasreddine et al., 2005)
- Able to understand study instructions and requirements
Who cannot join
- Non-stroke related causes of gait impairment
- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, dialysis, unresolved cancers e.g.,), active seizures within 3 months
- Anticipated life expectancy of < 6 months
- On subcutaneous or oral anti-coagulation
- Local factors potentially worsened by gait training: joint and muscle pains
- Lower limb pain VAS >4/10, active lower limb fractures or arthritis, fixed leg contractures, severe peripheral vascular disease, organomegaly or aortic aneurysms
Show all 12Show fewer
- Active unhealed skin wounds or inflammatory skin conditions over trunk and lower limbs,
- Severe visual impairment or visual neglect affecting navigation
- Known allergy to EEG gel (Recoverix)
- Presence of craniectomy skull defect
- Resident of nursing home or overseas country which may compromise attendance at research site
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Multimodal Profiling of Balance and Gait In Stroke Using EEG and Lower Limb Sensors: A Feasibility Study.
Balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. Researchers have effectively utilized EEG to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (BCI) motor profiling.
The study aims to test the EEG-BCI system to see if it's effective in understanding the balance and walking patterns of post-stroke populations.
Read the detailed description
Brain Computer Interface represent a groundbreaking field at the crossroads of neuroscience and engineering, serving as a direct communication link between the human brain and computer system.
Despite advancements in BCI technology, the electrocortical oscillations during human walking remain relatively unexplored, providing an opportunity for pioneering investigations.
The research highlights the feasibility of using EEG to decode neural patterns associated with various functions and aims to contribute to existing knowledge by using advanced EEG-based techniques to predict balance and gait patterns with the ultimate goal of tailoring rehabilitation approaches to individual patient needs.
- Conditions
- Stroke
- Being tested
- Clinical and technological-aided assessments and questionnaires
- Keywords
- Electroencephalographic (EEG), Brain Computer Interfaces
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and technological-aided assessments and questionnairesOther
Assessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Activities
To record EEG and EOG data from 64-Ch ActiCap EEG cap and electrode
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Goniometers
7 sensors to measure 2-axis joint angles at bilateral Hip, Knee and Ankle
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Secondary outcomes (5)
Fugl Meyer Assessment for Lower Limbs
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Berg Balance Scale
To assess functional balance
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Modified Clinical Test for Sensory Interaction in Balance
Assess complex sensory system to assist in determining which sensory system the individual relies upon (visual, somatosensory, vestibul)
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
10-metre Walk Test
To assess walking speed over a short distance
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
6-minute Walk Test
Determine the functional exercise capacity
Measured: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jul 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Dr Wee Seng Kwee, Principal investigator, Tan Tock Seng HospitalDr Karen Chua, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187467
- Sponsor's protocol ID
- DSRB 2023/00805
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2023
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Multimodal Profiling of Balance and Gait In Stroke Using EEG and Lower Limb Sensors: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT06187467
- Acronym / sponsor ID
- DSRB 2023/00805
- Conditions
- Stroke
- Keywords
- Electroencephalographic (EEG), Brain Computer Interfaces
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 2 Jan 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.
Balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. Researchers have effectively utilized EEG to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (BCI) motor profiling.
The study aims to test the EEG-BCI system to see if it's effective in understanding the balance and walking patterns of post-stroke populations.
Detailed description
Brain Computer Interface represent a groundbreaking field at the crossroads of neuroscience and engineering, serving as a direct communication link between the human brain and computer system.
Despite advancements in BCI technology, the electrocortical oscillations during human walking remain relatively unexplored, providing an opportunity for pioneering investigations.
The research highlights the feasibility of using EEG to decode neural patterns associated with various functions and aims to contribute to existing knowledge by using advanced EEG-based techniques to predict balance and gait patterns with the ultimate goal of tailoring rehabilitation approaches to individual patient needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in outpatient clinics
Key inclusion criteria (7 listed)
- First-ever clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors brain imaging
- Age 21 to 85 years
- At least ≥ 30 days post-stroke
- Gait impairments related to stroke
- Functional ambulation category -6 levels (Mehrholz et al, 2007): FAC ≥ 4, i.e. able to ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, non-level surfaces).
Key exclusion criteria (12 listed)
- Non-stroke related causes of gait impairment
- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, dialysis, unresolved cancers e.g.,), active seizures within 3 months
- Anticipated life expectancy of < 6 months
- On subcutaneous or oral anti-coagulation
- Local factors potentially worsened by gait training: joint and muscle pains
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 |
|---|---|---|
| Clinical and technological-aided assessments and questionnairesAssessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities. | Other | – |
Primary outcome
EEG Activities
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
To record EEG and EOG data from 64-Ch ActiCap EEG cap and electrode
Goniometers
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
7 sensors to measure 2-axis joint angles at bilateral Hip, Knee and Ankle
5 secondary outcomes
Fugl Meyer Assessment for Lower Limbs
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Berg Balance Scale
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Modified Clinical Test for Sensory Interaction in Balance
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
10-metre Walk Test
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
6-minute Walk Test
Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
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 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Dr Wee Seng Kwee principal investigator
Tan Tock Seng Hospital
Dr Karen Chua principal investigator
Tan Tock Seng Hospital
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 Tan Tock Seng Hospital at 1 site in Singapore.
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 7 inclusion and 12 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 7 Oct 2026. 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 Singapore. 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?
EEG Activities (time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)). 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?
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 7 Oct 2026.