NCT04694001已完成不适用
Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Wandercraft
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- The primary objective is to evaluate the incidence of treatment-emergent adverse events.
研究概览
简要总结
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.
It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.
The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
- •Patient presenting a FAC score of 0, 1, 2 or 3,
- •Patient whose etiological evaluation of the stroke has been complete,
- •Adult patient ≥18 years old,
- •Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.
排除标准
- •Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
- •Pregnant women
- •Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
- •Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
- •Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
- •Patient with a cardiac or respiratory contraindication to physical exertion,
- •Patient with a score below 18 on the Mini Mental State test,
- •Patient unable to deliver his/her consent,
- •Patient under legal protection,
- •Patient participating at the same time in another study,
- •Patients with morphological contraindications to the use of the Atalante exoskeleton.
结局指标
主要结局
The primary objective is to evaluate the incidence of treatment-emergent adverse events.
时间窗: Throughout study completion, an average of 6 days
The primary endpoint is measured through reported Adverse Events (AEs) including adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), adverse procedure effects (APE), and new findings (NFs).
次要结局
- Evaluate the patient's gait speed without the Atalante exoskeleton(At study start, day 1 and at study completion, up to 6 days)
- Evaluate the use of the Atalante exoskeleton(At study start, day 2 and at study completion, up to 6 days)
- Evaluate the patient's capability to stop the exoskeleton on time using the remote(At study mid term, up to 5 days)
- Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.(At study start, day 2 and at study completion, up to 6 days)
- Evaluate the patient's ability to walk without the Atalante exoskeleton(At study start, day 1 and at study completion, up to 6 days)
- Evaluate the patient's endurance without the Atalante exoskeleton(At study start, day 1 and at study completion, up to 6 days)
- Evaluate the patient's spasticity(At study start, day 1 and at study completion, up to 6 days)
- Evaluate the patient's pain(At study start, day 2 and at study completion, up to 6 days)
- Evaluate the patient's level of anxiety and depression(At study start, day 1 and at one week afetr the study completion, up to 12 days)
- Evaluate the patient's static and dynamic balance without the Atalante exoskeleton(At study start, day 1 and at study completion, up to 6 days)
- Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton(At study completion, up to 6 days)
研究者
研究点 (12)
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