The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- functional ambulatory category
研究概览
简要总结
This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
详细描述
Regaining a mobility level post-surgery that comes close to the patient's previous mobility as a baseline is the goal. It is commonly accepted that conventional physiotherapy after burn injury has a positive impact on muscle strength, range of motion, pain or gait performance which all impact patient mobility. Wearable robots that assist walking centered on the hip joint of the lower extremities are appearing. This wearable robot is a positive effect in terms of increased energy efficiency and posture during walking. This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50%of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. This study excluded patients with fourth-degree burns (involving muscles, tendons, and bone injuries), severe communication disorders because of intellectual impairment and psychological problems. The specific exclusion criteria were as follows. Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more. Patients with heart and circulatory conditions that may affect gait training. Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
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
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years
- •had a Functional Ambulation Category (FAC) score of 3 or higher
排除标准
- •fourth-degree burns (involving muscles, tendons, and bone injuries)
- •severe communication disorders because of intellectual impairment and psychological problems
- •Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more.
- •Patients with heart and circulatory conditions that may affect gait training.
- •Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.
结局指标
主要结局
functional ambulatory category
时间窗: 12 weeks
Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used.
次要结局
- 6-Minute Walk Test (6MWT)(12weeks)
- visual analogue scale (VAS)(12 weeks)
- sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases(12 weeks)
- 6-Minute Walk Test (6MWT)(12weeks)
- visual analogue scale (VAS)(12 weeks)
- sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases(12 weeks)
研究者
So Young Joo
Principal Investigator, Department of rehabilitation medicine of Hangang Sacred heart hospial
Hangang Sacred Heart Hospital
