Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Wandercraft
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
研究概览
简要总结
The SPIRIT study is interventional, national, 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 a non-traumatic acute-subacute hemiplegia. The primary endpoint is defined by the patient's ability to perform the 10 MWT with the Atalante system.
The study will include at least 12 patients and takes place in three french rehabilitation centers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with non-traumatic vascular hemiplegia in acute subacute phase (15 days to 6 months) hospitalized in rehabilitation center,
- •Patients presenting a FAC score of 0, 1 or 2,
- •Patient with ischemic or hemorrhagic stroke of which etiological evaluation is complete,
- •Adult patient ≥18 years old,
- •Patient able to verticalize on a daily basis and having a stabilized blood pressure,
- •Patient with stable medical condition at the time of inclusion in the study (absence of infectious and cardiorespiratory events),
- •Patient's height is at least 1m55,
- •Lengths of patient's lower limb are in the following intervals:
- •Thigh (distance gluteus maximus - patella): 56.8 and 64.8 cm,
- •Distance between the ground and the joint space of the knee (to be measured while wearing the shoes the patient intends to wear with Atalante):
- •45.7-60.7 cm for patient with an ankle dorsiflexion ≥ 16°
- •45.7-57.7 cm for patient with an ankle dorsiflexion > 13° et < 16°
- •45.7-56.7 cm for patient with an ankle dorsiflexion > 10° et ≤ 13°
- •45.7-55.7 cm for patient with an ankle dorsiflexion ≥ 0° et ≤ 10°
- •Intertrochanteric distance lower or equal to 46.0 cm when seated,
- •Maximum weight: 90 kg,
- •Patient able to read and write French and who have signed an informed consent form.
排除标准
- •Ranges of motion below:
- •Hip: 90° flexion, 5° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation
- •Knee: 5° extension, 110° flexion
- •Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
- •Patient whose joint centers cannot be aligned Atalante's system,
- •Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
- •Pregnant or lactating women,
- •Medical history of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis,
- •Patient with a cardiac contraindication to physical exertion,
- •Evolutive intercurrent disease: venous thrombosis, hypotension,
- •Patient unable to deliver his/her consent,
- •Patient under legal protection,
- •Patient participating at the same time in another study.
研究组 & 干预措施
Non-traumatic hemiplegia in post stroke acute subacute phase
干预措施: Use of the Atalante exoskeleton (Device)
结局指标
主要结局
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
时间窗: At study completion, 10 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
时间窗: At study mid-term, 6 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system.
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
时间窗: At study mid-term, 7 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
时间窗: At study mid-term, 8 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
时间窗: At study completion, 9 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
次要结局
- Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification (FAC).(At baseline, day 0 and at study completion, up to 10 days)
- Evaluate the settings of the walking parameters of the exoskeleton deemed most efficient by the patient (step length, cadence)(Day 2 until study mid term, day 5)
- Evaluate the assistive control settings(Day 2, day 4)
- Evaluate the patient's ability to perform weight transfer on the hemiplegic side or the healthy side(Day 2, day 4)
- Evaluate the patient's ability to perform a semi-squat(Day 3, day 5)
- Evaluate the level of assistance needed by the patient from the healthcare staff to perform tests(Throughout study completion, an average of 10 days)
- Evaluate the time needed for the patient to don and doff(At study completion, day 10)
- Evaluate the patient's physical and cognitive conditions using the Berg Balance Scale(At baseline, day 0 and at study completion, up to 10 days)
- Evaluate the patient's physical and cognitive conditions(At baseline, day 0)
- Evaluate the level of effort perceived during each test by using the Borg scale(Throughout study completion, an average of 10 days)
- Evaluate the level of security perceived during each test by using a 5-level Likert scale(Throughout study completion, an average of 10 days)
- Evaluate the level of anxiety of patient related to the use of the exoskeleton(At study start, day 1 and at study completion, up to 10 days)
- Evaluate the emergence of musculoskeletal disorders in the therapist(At baseline, day 0 and at study completion, up to 10 days)