StrokeNCT07760116
Robotic Exoskeleton Gait Training With and Without Brain-Computer Interface Control After Stroke
A study testing Conventional exoskeleton gait training in people with Stroke and Hemiparesis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
After a stroke, many people have trouble walking. One way to practice walking again is with a wearable robot, called an exoskeleton, that supports the legs and guides them through a walking pattern. In most systems, a therapist or a sensor decides when each step starts. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis, Gait Disorders, Neurologic
- What is being tested?
- Conventional exoskeleton gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 30 Jul 2026
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 80 years
- Unilateral lower-limb weakness attributable to a stroke sustained within the previous year
- Able to complete the Timed Up and Go (TUG) test at baseline
- Able to follow training instructions
- Provided written informed consent
Who cannot join
- Baseline Timed Up and Go (TUG) time of less than 20 seconds
- Significant pain in the lower limbs
- Prior lower-limb surgery
- Neuromuscular disease affecting gait
- Cardiopulmonary condition contraindicating gait training
- Cognitive or cooperative deficits preventing the participant from following training instructions
- Inability to perform the Timed Up and Go (TUG) test at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Therapeutic Effects Between Traditional and Brain-Computer Interface-Controlled Exoskeleton Gait Training in Post-Stroke Patients: A Randomized Comparative Study
After a stroke, many people have trouble walking. One way to practice walking again is with a wearable robot, called an exoskeleton, that supports the legs and guides them through a walking pattern. In most systems, a therapist or a sensor decides when each step starts.
This study looked at whether it helps to let a person's own brain activity start each step instead. Sensors placed on the scalp recorded brain signals. A computer read these signals and told the robot when to take a step. This way of controlling a device is called a brain-computer interface.
Read more
People who had a stroke within the past year took part. They were placed by chance into one of two groups. One group practiced walking with the robot in the usual way. The other group practiced with the robot controlled by their own brain signals. Both groups trained twice a week for 4 weeks.
Before and after the training, the study team measured how far each person could walk in 6 minutes, how long it took to stand up and walk a short distance and sit down again, how strong the knee muscles were, and how each person rated their own health and well-being. The study compared how much the two groups improved.
- Conditions
- Stroke, Hemiparesis, Gait Disorders, Neurologic
- Being tested
- Conventional exoskeleton gait training, BCI-controlled exoskeleton gait training
- Medical subject headings
- Stroke, Paresis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional exoskeleton gait trainingDevice
Powered lower-limb exoskeleton gait training, twice weekly for 4 weeks. Each session included sit-to-stand, walking, and stand-to-sit phases. Phase transitions were triggered externally by a trained study assistant. No EEG decoding was used.
BCI-controlled exoskeleton gait trainingDevice
Same exoskeleton training schedule and phases. Each session began with a 6-minute EEG decoder calibration (theta, movement-related cortical potential, alpha). Each phase transition was triggered in a closed loop by the participant's decoded intent.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Not described Receives: Device: Conventional exoskeleton gait training |
| BCI-Controlled | Experimental | Not described Receives: Device: BCI-controlled exoskeleton gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Test (6MWT) distance
Distance walked in 6 minutes along a flat 30-meter indoor corridor, recorded in meters. Participants were instructed to cover as much distance as possible. The same corridor was used for all assessments at both time points. Greater distance indicates better walking capacity.
Measured: Baseline and 4 weeks (immediately before and after the 4-week training program)
Secondary outcomes (1)
Change in SF-12 Physical Component Summary (PCS) score
Physical component summary score of the 12-item Short Form Health Survey. Scores are norm-based to a population mean of 50 with a standard deviation of 10. Higher scores indicate better physical health-related quality of life.
Measured: Baseline and 4 weeks (immediately before and after the 4-week training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion30 Jul 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760116
- Sponsor's protocol ID
- CF21277A-1
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including baseline characteristics and pre- and post-intervention values for all primary and secondary outcome measures, will be made available to qualified investigators upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Effects Between Traditional and Brain-Computer Interface-Controlled Exoskeleton Gait Training in Post-Stroke Patients: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07760116
- Acronym / sponsor ID
- CF21277A-1
- Conditions
- Stroke, Hemiparesis, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 12 Aug 2026 (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 a stroke, many people have trouble walking. One way to practice walking again is with a wearable robot, called an exoskeleton, that supports the legs and guides them through a walking pattern. In most systems, a therapist or a sensor decides when each step starts.
This study looked at whether it helps to let a person's own brain activity start each step instead. Sensors placed on the scalp recorded brain signals. A computer read these signals and told the robot when to take a step. This way of controlling a device is called a brain-computer interface.
People who had a stroke within the past year took part. They were placed by chance into one of two groups. One group practiced walking with the robot in the usual way. The other group practiced with the robot controlled by their own brain signals. Both groups trained twice a week for 4 weeks.
Before and after the training, the study team measured how far each person could walk in 6 minutes, how long it took to stand up and walk a short distance and sit down again, how strong the knee muscles were, and how each person rated their own health and well-being. The study compared how much the two groups improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: Conventional exoskeleton gait training |
| BCI-Controlled | Experimental | Device: BCI-controlled exoskeleton gait training |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 to 80 years
- Unilateral lower-limb weakness attributable to a stroke sustained within the previous year
- Able to complete the Timed Up and Go (TUG) test at baseline
- Able to follow training instructions
- Provided written informed consent
Key exclusion criteria (7 listed)
- Baseline Timed Up and Go (TUG) time of less than 20 seconds
- Significant pain in the lower limbs
- Prior lower-limb surgery
- Neuromuscular disease affecting gait
- Cardiopulmonary condition contraindicating gait training
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 |
|---|---|---|
| Conventional exoskeleton gait trainingPowered lower-limb exoskeleton gait training, twice weekly for 4 weeks. Each session included sit-to-stand, walking, and stand-to-sit phases. Phase transitions were triggered externally by a trained study assistant. No EEG decoding was used. | Device | Conventional |
| BCI-controlled exoskeleton gait trainingSame exoskeleton training schedule and phases. Each session began with a 6-minute EEG decoder calibration (theta, movement-related cortical potential, alpha). Each phase transition was triggered in a closed loop by the participant's decoded intent. | Device | BCI-Controlled |
Primary outcome
Change in 6-Minute Walk Test (6MWT) distance
Time frame: Baseline and 4 weeks (immediately before and after the 4-week training program)
Distance walked in 6 minutes along a flat 30-meter indoor corridor, recorded in meters. Participants were instructed to cover as much distance as possible. The same corridor was used for all assessments at both time points. Greater distance indicates better walking capacity.
1 secondary outcome
Change in SF-12 Physical Component Summary (PCS) score
Time frame: Baseline and 4 weeks (immediately before and after the 4-week training program)
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including baseline characteristics and pre- and post-intervention values for all primary and secondary outcome measures, will be made available to qualified investigators upon reasonable request to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional exoskeleton gait training in people with Stroke and Hemiparesis, run by Taichung Veterans General Hospital 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 5 inclusion and 7 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 12 Aug 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 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?
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?
Change in 6-Minute Walk Test (6MWT) distance (time frame: Baseline and 4 weeks (immediately before and after the 4-week training program)). 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 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.