Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients

NCT07411703 | Enrolling By Invitation DMC

• 1 other identifier: CHGH-(1140)113-70
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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).

Interventions

NDT Gait Training System DEVICE

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult stroke survivors with hemiplegia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112050, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Szu-Fu Chen

  MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): March 26, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)