Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke
• Intervention / Treatment: Device: NDT Gait Training System

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112050
    • Cheng Hsin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult stroke survivors with hemiplegia

Description

Inclusion Criteria:

• Age ≥ 20 years, first-ever stroke, with Brunnstrom stage III to IV of the affected lower limb motor recovery.
• Functional Ambulation Category (FAC) level IV.
• Ability to ambulate on level ground without assistive devices.
• Ability to understand instructions and cooperate with assessments.

Exclusion Criteria:

• Presence of severe spinal cord injury or peripheral neuropathy.
• Unstable gait requiring assistive devices, or participants at high risk of falling.
• Severe impairment in vision, hearing, or cognition, making them unable to comply with assessments.
• Lower limb fracture within the past 6 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swing phase asymmetry	Swing-phase asymmetry, defined as the difference in swing-phase proportion between the non-paretic and paretic limbs- will be calculated from toe-off to heel-strike timing within the gait cycle, using the wearable inertial measurement units (IMUs) before and after the NDT gait training intervention .	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Pelvic rotation amplitude	Gait data will be acquired via wearable IMUs before and after the NDT gait training intervention, and the amplitude of pelvic rotation will be derived from axial angular velocity data.	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed	Walking speed will be quantified during gait using IMU-based measurements, and the average walking speed for each stage will be computed from recorded motor-driven motion data and reported in meters per second (m/s).	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).

Collaborators and Investigators

• Sponsor: Cheng-Hsin General Hospital
• Investigators: Principal Investigator: Szu-Fu Chen, MD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): March 26, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: CHGH-(1140)113-70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No