NCT06830707已完成不适用
Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Late Subacute and Chronic Stroke Patients, Single-Center, Single-blinded Cross-over Prospective Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Comparison of the change in walking speed
研究概览
简要总结
The aim of this study was to investigate the effects of lower limb constraint induced motor therapy using the robotic rehabilitation device on ambulatory function in chronic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients with hemiparesis due to ischemic or hemorrhagic stroke
- •Patients in the late subacute or chronic phase, at least 3 months after the onset of stroke
- •Individuals who can independently walk with a Functional Ambulatory Category score of 3 or higher
- •Patients who are able to use Torque-Assisted Exoskeletal Wearable Device Height: 140 cm to 190 cm Weight: 80 kg or less Shoe size: 230 mm to 290 mm
- •Patients who were independent walkers and had no difficulties performing activities of daily living (mRS ≤ 1)
排除标准
- •Patients with severe cognitive impairment (MMSE <10) or significant communication difficulties such as speech disorders
- •Patients with spasticity in one-sided lower limbs, rated 2 or higher on the Modified Ashworth Scale (MAS)
- •Patients with severe musculoskeletal disorders of the lower limbs
- •Patients with contractures that limit the range of motion in the lower limbs
- •Patients with an apparent leg length discrepancy of 2 cm or more
- •Patients with fractures, open trauma, or non-healing ulcers in the lower limbs
- •Patients with serious internal diseases such as cardiovascular disease or pulmonary disease that make it difficult to use Exoskeletal Wearable Device for walking therapy
- •Patients with a history of osteoporotic fractures
- •Patients with other neurological disorders affecting walking (e.g., Parkinson's disease, multiple sclerosis, etc.)
- •Any other cases where the investigator determines that participation in this study is inappropriate
研究组 & 干预措施
Torque-Assisted Exoskeletal Wearable Device group
Experimental
The treatment comprised 5 robot-assisted gait training sessions over a 2-week period, followed by 10 lower limb Constraint Induced Movement Therapy(CIMT) sessions with a torque assisted exoskeleton.
干预措施: experimental group (Device)
结局指标
主要结局
Comparison of the change in walking speed
时间窗: 3 weeks follow up
Comparison of the change in walking speed before and after 5 sessions of walking training versus 10 sessions of CIMT exercise training
次要结局
未报告次要终点
研究者
Won Hyuk Chang
professor
Samsung Medical Center
研究点 (1)
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