Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

Официальное название

Gait Training for Hemiplegic Stroke Patients: Employing a Stationary Neuro-developmental Trainer With Auditory Cues

Обзор

This study aims to evaluate the effectiveness of a novel mobile neurodevelopmental treatment (NDT) gait training device for patients recovering from stroke. Stroke is a major cause of disability worldwide, and many survivors experience difficulty with walking and require long-term rehabilitation. NDT is a widely used rehabilitation approach that focuses on improving motor control through techniques such as facilitation, inhibition, and key point control. However, traditional NDT gait training can be physically demanding for therapists and often limits the training intensity and duration for patients. To address these challenges, this study introduces an automated NDT gait training device that replicates therapist techniques using mechanical support and sensory feedback. The system uses bilateral dynamic assistance at the waist, auditory cues, and wearable inertial measurement units (IMUs) to help patients practice natural and symmetric walking patterns on the ground, instead of being restricted to treadmill training. The IMUs also provide objective gait data to assess improvement in gait symmetry, pelvic rotation, walking speed, and cadence. The primary goal is to assess changes in these gait parameters before and after NDT-based intervention. The study plans to enroll 40 adult stroke survivors (aged 20 and older) over a 3-year period starting from May 1, 2024.

Вмешательства

• Устройство NDT Gait Training System
  The intervention includes a NDT gait training device that mimics therapist techniques through mechanical assistance, synchronized with auditory feedback and real-time gait analysis using IMU sensors.

Первичные конечные точки

• Pelvic rotation [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).]
• Step length [Срок оценки: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).]

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

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Cheng Hsin General Hospital — Taipei

Идентификаторы

NCT: NCT07395544 · CHGH-(1069)112A-60

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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