The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Berg balance scale
研究概览
简要总结
Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups.
Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment.
The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group.
Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within 4 weeks of onset of first stroke
- •Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
- •Adult male or female over 50 years of age
- •Those who have consented in writing to this clinical trial
- •A person who understands the purpose of the clinical trial and can adapt well to the treatment process
排除标准
- •Those with lower motor neuron lesions
- •A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
- •Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
- •A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
- •Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
- •Those with the construction of the lower extremities
- •Those with deep vein thrombosis or arterial vascular disease of the lower extremities
- •Pregnant women
- •Not appropriate according to the judgment of other researchers
研究组 & 干预措施
Intervention group
Robot assisted inclined bed treatment and FES
干预措施: Robot assisted inclined bed treatment and FES (Device)
Control group
conventional inclined bed treatment
干预措施: conventional inclined bed treatment (Device)
结局指标
主要结局
Berg balance scale
时间窗: 8weeks after
A tool to evaluate balance
Locomotion level of FIM (functional independence measure)
时间窗: 8weeks after
Indicator to evaluate independence in performing daily life movements
Fugl-Meyer Assessment (lower)
时间窗: 8weeks after
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Motricity Index
时间窗: 8weeks after
A tool used to evaluate motor power.
FAC (Functional ambulatory scale)
时间窗: 8weeks after
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Motricity Index
时间窗: 4weeks after
A tool used to evaluate motor power.
Fugl-Meyer Assessment (lower)
时间窗: before intervention
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Fugl-Meyer Assessment (lower)
时间窗: 4weeks after
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Motricity Index
时间窗: before intervention
A tool used to evaluate motor power.
FAC (Functional ambulatory scale)
时间窗: before intervention
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
FAC (Functional ambulatory scale)
时间窗: 4weeks after
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Locomotion level of FIM (functional independence measure)
时间窗: before intervention
Indicator to evaluate independence in performing daily life movements
Locomotion level of FIM (functional independence measure)
时间窗: 4weeks after
Indicator to evaluate independence in performing daily life movements
Berg balance scale
时间窗: before intervention
A tool to evaluate balance
Berg balance scale
时间窗: 4weeks after
A tool to evaluate balance
次要结局
未报告次要终点