Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke, Multi-center, Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 10 Meter Walk Test
研究概览
简要总结
The aim of this study is to evaluate the safety of gait training using a hip-assist powered exoskeleton. This will be assessed by collecting all device-related adverse events occurring during the entire intervention period, which consists of a total of 10 sessions within 5 weeks across two different gait rehabilitation protocols.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 85 years.
- •Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.
- •Patients in the late subacute or chronic phase, with stroke onset of 3 months or more (in cases of recurrent stroke, based on the most recent event). Functional Ambulation Category (FAC) score of 3 or higher.
- •Patients capable of safely wearing the hip-assist powered exoskeleton and using it with minimal assistance.
- •Height: 140 cm - 190 cm
- •Weight: 80 kg or less
- •Patients who were capable of independent walking and had no disability in daily self-care activities prior to stroke onset (based on the last stroke for recurrent patients). (mRS ≤2)
- •Patients who have received approval for study participation from the attending medical staff.
排除标准
- •Severe cognitive impairment (Mini-Mental State Examination [MMSE] < 10) or severe speech impairment/aphasia.
- •History of major orthopedic surgery, such as hip, knee, or ankle arthroplasty, within the last 3 months.
- •Fractures, open wounds, or unhealed ulcers in the lower extremities.
- •Patients for whom gait training with the powered orthopedic device is difficult due to severe medical conditions, such as cardiovascular or pulmonary diseases.
- •History of osteoporotic fractures.
- •Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).
- •Any other cases where the investigator deems participation in the study to be inappropriate.
研究组 & 干预措施
gait assistance mode group
Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton
干预措施: gait assistance mode group (Device)
Resistance mode
Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton
干预措施: Resistance mode (Device)
结局指标
主要结局
10 Meter Walk Test
时间窗: Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)
(lower limb motor score in 10 Meter Walk test at post-intervention) - (lower limb motor score in 10 Meter Walk Test at baseline) Higher scores mean a better outcome
次要结局
未报告次要终点
研究者
Won Hyuk Chang
professor
Samsung Medical Center