NCT04110561已完成不适用
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Wandercraft
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- The primary endpoint of the clinical investigation is defined by the success or failure at the 10 Meter Walk Test (10mWT) at the latest session.
研究概览
简要总结
The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.
The principal objective is to assess the performance of the Atalante system in performing ambulatory functions with motor complete SCI patients characterized by the success rate in performing a 10mWT at the last session of training with the Atalante system.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motor complete traumatic Spinal Cord Injury (AIS A and B) since at least 4 months
- •Spinal Injury Level between AIS T5 and AIS T12
- •Able to verticalize on a daily basis
- •Height: between approximately 1.60 and 1.90 m. More specifically, Atalante is able to accommodate the following limb lengths:
- •Thigh: 380-460 mm
- •Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
- •457-607 mm for patient with an ankle dorsiflexion ≥ 16°
- •457-577 mm for patient with an ankle dorsiflexion between 13° et 16°
- •457-567 mm for patient with an ankle dorsiflexion between 10° et 13°
- •457-557 mm for patient with an ankle dorsiflexion between 0° et 10° o Hip width less of equal to 460 mm when seated
- •Maximum weight: 90 kg
- •Patient having given his written consent
排除标准
- •Patients whose joint centers cannot be aligned Atalante's
- •Ranges of motion below:
- •Hip: 115° flexion, 15° 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
- •Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
- •Pregnant or lactating woman
- •Unbalanced psychiatric or cognitive status which may interfere with an appropriate use of the device
- •Other neurological disorder
- •History of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis
- •Active implantable medical device
- •Evolutive intercurrent disease: pressure sore, infection, venous thrombosis
- •Unstable and unhealed limb and pelvic fracture
- •Unstable spine
- •Severe illness which may interfere with the verticalized posture and tolerance to effort
- •Evolutive osteoma
- •Syringomyelia
研究组 & 干预措施
Spinal Cord Injury patients with motor complete paralysis
Other
干预措施: Use of the Atalante exoskeleton (Device)
结局指标
主要结局
The primary endpoint of the clinical investigation is defined by the success or failure at the 10 Meter Walk Test (10mWT) at the latest session.
时间窗: At study completion, up to 3 weeks
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. A clear pathway of at least 10-meter length is drawn. The start and the end point of a 10-m walkway is marked by lines. The patient starts a few steps prior the starting line; during the few steps needed to reach the starting line, the physiotherapist should stabilize the exoskeleton in the frontal plane. When the patient's first foot crosses the starting line, the test begins, and the stopwatch is started. The stopwatch is stopped at the end of the 10 meters in case of success, that is to say when the patient crosses the end line. The total time taken to ambulate is recorded. The distance covered is then divided by the total time (in seconds) taken to ambulate and recorded in meters per seconds. In case of failure, the distance walked by the patient is measured and recorded, and the speed to walk this distance is calculated as described above.
次要结局
- The average walking speeds during the 10mWT at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Capacity of a standing patient to reach a sitting position as defined by the test "Sit down" at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Heart rate measurement at rest and after the 10mWT at the 1st, 6th and 12th sessions.(At study start, day 1, at study mid-term, 10 days and at study completion, up to 3 weeks)
- Time of installation of the patient in the exoskeleton at the 12th session.(At study completion, up to 3 weeks)
- The maximum distance walked during the 10mWT at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Capacity of the patient to perform verticalization as defined by the test "Stand-up" at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Capacity of patient in walking defined by Success / Failure on a 10mWT test at the 6th session.(At study mid-term, 10 days in average)
- Ability of the patient to maintain a stand still position for 2 minutes as defined by the test "Stand without support for 2 minutes" at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Ability of the patient to lean with extended arm in a standing position (90° arms) at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Ability of the patient to perform a U-turn in less than 3 minutes as defined by the test "Make a U-turn" at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Average scores on Borg CR-10 simple perception scale for the perceived exertion at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Comparison of the Bristol scale before the 1st session and after the 12th session.(At study start, day 1 and at study completion, up to 3 weeks)
- Definition of the voiding mode at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
- Qualiveen score at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
- Average scores of safety perceived by the patient on a 7-point Likert scale 7 levels at the 6th and 12th sessions.(At study mid-term, 10 days in average and at study completion, up to 3 weeks)
- Observation of the skin condition was made before and after each session on the subject's back, thighs, knees and feet.(Throughout study completion, an average of 3 weeks)
- Comparison of the Visual Analogue Pain Scale at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
- Comparison of the NBD score before the 1st session and after the 12th session.(At study start, day 1 and at study completion, up to 3 weeks)
- Patient Global Impression of Improvement (PGI-I) at the 12th session.(At study completion, up to 3 weeks)
- Average scores of the 7-point Likert scale for ergonomics at the 12th session.(At study completion, up to 3 weeks)
- Average scores of the 7-point Likert scale for exoskeleton attachment questionnaire at the 12th session.(At study completion, up to 3 weeks)
- Comparison of the NPSI scores at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
- Assistance level for each fastener at the 12th session.(At study completion, up to 3 weeks)
- Adverse events collection at each session.(Throughout study completion, an average of 3 weeks)
- Spasticity according to the Modified Ashworth scale at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
- Evaluation of sitting balance using the Boubee test at the 1st and 12th sessions.(At study start, day 1 and at study completion, up to 3 weeks)
研究者
研究点 (4)
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