Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Swing phase asymmetry [Срок оценки: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).]
• Pelvic rotation amplitude [Срок оценки: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).]
• Walking speed [Срок оценки: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Тайвань · 1 центр

• Cheng Hsin General Hospital — Taipei

Идентификаторы

NCT: NCT07411703 · CHGH-(1140)113-70

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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