ClinicalTrials.gg
CompletedNCT07760116Updated Aug 12, 2026

Robotic Exoskeleton Gait Training With and Without Brain-Computer Interface Control After Stroke

An interventional study of Conventional exoskeleton gait training and BCI-controlled exoskeleton gait training in Stroke, Hemiparesis and Gait Disorders, Neurologic, sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 394 studies in Stroke with a site in Taiwan — 74 open to participants now, 84 under way, 4 of them phase 3. Stroke · Taiwan.

Enrollment
200th of 337
42 · median 54
Started
2025
with 21 others
No phase
261 of 394
64 open now
Registered
391st of 394
by date

Among the 394 studies in Stroke with a site in Taiwan, this one is the 200th largest by enrollment of the 337 interventional ones that give a count, is one of 22 that started in 2025, is one of 261 with no phase, and was the 391st registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 42 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Open to participants now

74 of the 394 studies in Stroke with a site in Taiwan are open now, in 12 countries. Each count lists the studies.

All 74 open studies →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 30 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 394 studies in Stroke with a site in Taiwan, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Stroke
  • Hemiparesis
  • Gait Disorders, Neurologic
04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Conventional

    Device: Conventional exoskeleton gait training

  • Experimental
    BCI-Controlled

    Device: BCI-controlled exoskeleton gait training

Interventions

  • DeviceConventional exoskeleton gait training

    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.

  • DeviceBCI-controlled exoskeleton gait training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline and 4 weeks (immediately before and after the 4-week training program)

07

Study locations

1 site
  • Taichung Veterans General Hospital
    Taichung, 407219, Taiwan
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 6 months after publication, with no end date

Access criteria: Requests will be reviewed by the study investigators. Requesting investigators must provide a methodologically sound proposal and a signed data access agreement. Approval of the institutional review board may be required.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Dec 2025, 11 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 11 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 12, 2026
StartActual
Jan 1, 2025
Primary completionActual
Dec 31, 2025
CompletionActual
Jul 30, 2026
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07760116
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Jan 1, 2025
Primary completion
Dec 31, 2025
Completion
Jul 30, 2026
Last update
Aug 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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