NCT07411703

Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients

Gait Training for Hemiplegic Stroke Patients: Employing an Automated Trainer With Sensory Cues

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Cheng-Hsin General Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of an automated mobile gait training device developed based on neurodevelopmental treatment (NDT) principles for patients with hemiplegic stroke. Stroke is a major cause of long-term disability, and many survivors experience impaired walking ability that affects their independence and daily functioning. NDT is a commonly used rehabilitation approach that emphasizes therapist-guided facilitation of normal movement patterns during gait training. However, conventional NDT gait training is physically demanding and time-consuming for therapists, which may limit the amount of repetitive gait practice patients can receive. To address these limitations, this study introduces a power-assisted gait training device capable of reproducing key therapeutic interventions typically provided by therapists. The system uses synchronized dynamic assistance, auditory cues, and wearable inertial measurement units (IMUs) to support gait training on the ground and facilitate more natural and repetitive walking practice. The IMUs provide objective gait data that are used to evaluate changes in swing-phase symmetry, pelvic rotation amplitude, and walking speed. The primary goal of this study is to assess changes in these gait parameters following training with the proposed NDT-based assistive device. The study plans to enroll 60 adult stroke survivors (aged 20 and older) over a 3-year period starting from March 26, 2025.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	NDT Gait Training System	The intervention consists of an NDT gait training device that replicates therapist-applied techniques through mechanical assistance, combined with synchronized auditory feedback and real-time gait analysis using IMU sensors.

Timeline

• Start date: 2025-03-26
• Primary completion: 2028-03-26
• Completion: 2029-03-26
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Taiwan