Gait Training for Hemiplegic Stroke Patients: Employing a Stationary Neuro-developmental Trainer With Auditory Cues
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pelvic rotation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NDT gait training group
NDT gait trainer which can automatically repeat NDT intervention, thereby alleviating therapists' workload and extending patients' training time. They analyzed therapists' intervention in manual NDT training and concluded that therapists cued subjects' anterior superior iliac spines (ASISs) when perceiving opposite heel strikes (HSs).
干预措施: NDT Gait Training System (Device)
结局指标
主要结局
Pelvic rotation
时间窗: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
The gait parameter will be collected using wearable inertial measurement units (IMUs) before and after the NDT gait training intervention and pelvic rotation will be measured through axial angular velocity
Walking speed
时间窗: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed will be estimated from IMU during walking and reported in meters per second (m/s).
Step length
时间窗: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).
Step length will be derived from IMU-based spatiotemporal gait data collected during overground walking and reported in meters (m).
次要结局
未报告次要终点