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

NCT07760116 | Completed

• 1 other identifier: CF21277A-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  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

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

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Device: Conventional exoskeleton gait training

BCI-Controlled

EXPERIMENTAL

Device: BCI-controlled exoskeleton gait training

Interventions

Conventional exoskeleton gait training DEVICE

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.

Conventional

BCI-controlled exoskeleton gait training DEVICE

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.

BCI-Controlled

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

MeSH Terms

Conditions

Stroke; Paresis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: July 30, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

TW (1)