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临床试验/NCT07277166
NCT07277166招募中不适用

The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study

Hangang Sacred Heart Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月13日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

So Young Joo

Principal Investigator, Department of rehabilitation medicine of Hangang Sacred heart hospial

Hangang Sacred Heart Hospital

研究点 (2)

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