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

NCT07760116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

  • Stroke
  • Hemiparesis
  • Gait Disorders, Neurologic

Interventions

DEVICE

Conventional 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.

DEVICE

BCI-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.

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2026-07-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760116 on ClinicalTrials.gov