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Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases

2021年4月6日 更新者：MarsiBionics

Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I

This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

6

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
    • Madrid
      • Arganda Del Rey、Madrid、西班牙、28500
        • MarsiCare

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 14年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Maximum user weight of 35 kg
  • Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
  • Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
  • Pelvis width (between greater trochanters) from 24 to 35 cm.
  • Ability to achieve ankle dorsiflexion to 90˚
  • 20º or more hip flessum.
  • 20º or more knee flessum.
  • No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
  • Informed consent signed by legal guardians.
  • Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
  • Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
  • Patient being followed according to the recommended standards for his or her illness
  • Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
  • No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
  • Score on the FAC scale between 1 and 4 points
  • Not being able to walk without assistance

Exclusion Criteria:

  • Patient's inability to follow simple instructions and/or communicate discomfort.
  • Invasive or non-invasive daytime ventilation.
  • Orthostatic hypotension.
  • 20º or more hip flessum.
  • 20º or more knee flessum
  • Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
  • Severe skin injury to the lower extremities.
  • Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
  • History of fracture without trauma.
  • History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
  • Not receiving regular standing rehabilitation sessions.
  • Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
  • Refusal of the patient or legal guardian to include the child in the study.
  • Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：设备可行性
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention Group
9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks.
设备：Exoskeleton rehabilitation
The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
其他名称：
  • ATLAS2030
  • ATLAS
  • robot-assisted therapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
安全性作为严重器械不良事件的数量
大体时间：每次使用外骨骼后，持续 5 周
存在涉及参与者或治疗师的严重设备不良事件
每次使用外骨骼后，持续 5 周

次要结果测量

结果测量
措施说明
大体时间
跌倒发生率 [使用设备期间跌倒的次数]
大体时间：在设备使用期间，持续 5 周
参与者或治疗师发生跌倒事件的次数
在设备使用期间，持续 5 周
皮肤完整性 [与设备相关的皮肤损伤数量]
大体时间：每次使用外骨骼前后，持续 5 周
皮肤完整性衡量为皮肤损伤的数量
每次使用外骨骼前后，持续 5 周
痉挛 [改良 Ashworth 量表]
大体时间：在使用设备之前和之后的 5 周内
使用设备前后出现的痉挛
在使用设备之前和之后的 5 周内
身体评估[检测到的身体伤害数量]
大体时间：在使用设备之前和之后的 5 周内
存在组织损伤的物理评估
在使用设备之前和之后的 5 周内
肌肉力量 [用 N 中的手持式测力计测量]
大体时间：在第一天、第三周和第五周
测量臀部、膝盖和脚踝肌肉的肌肉力量
在第一天、第三周和第五周
ROM [用测角仪测量]
大体时间：在第一天、第三周和第五周
运动范围
在第一天、第三周和第五周
功能移动性 [功能性步行类别量表]
大体时间：在第一天、第三周和第五周
使用和不使用设备的功能移动性
在第一天、第三周和第五周
步行距离 [6MWT]
大体时间：在第一天、第三周和第五周
6MWT 使用设备记录
在第一天、第三周和第五周
设备故障[作为设备故障的数量和类型]
大体时间：在设备使用期间，持续 5 周
任何设备故障都会被记录下来
在设备使用期间，持续 5 周
Safety as presence of adverse events or adverse device events
大体时间：after each use of exoskeleton, for 5 weeks
Presence of a device adverse events where the participant or therapist is involved.
after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
大体时间：after each use of exoskeleton, for 5 weeks
Measured as time per event for at each therapy session.
after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
大体时间：At each use of exoskeleton, for 5 weeks
Measured as time to carry out the transfers
At each use of exoskeleton, for 5 weeks
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
大体时间：At the end of the study, at the 5th week
Measured as abandon ratio
At the end of the study, at the 5th week
Accessibility [number of potential participants in relation with the included participants]
大体时间：At the end of the study, at the 5th week
Measured as relation between number of participants and number of potential participants which weren't recruited
At the end of the study, at the 5th week
Pain [Wong-Baker FACES Pain Rating Scale]
大体时间：Before and after the use of the device, during 5 weeks
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Before and after the use of the device, during 5 weeks
Fatigue [Borg Rating Scale of Perceived Exertion]
大体时间：Before and after the use of the device, during 5 weeks
Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome.
Before and after the use of the device, during 5 weeks
Heart rate [sphygmomanometer]
大体时间：Before and after the use of the device, during 5 weeks
Number of heart bets per minute
Before and after the use of the device, during 5 weeks
System Usability [System Usability Scale]
大体时间：At the end of the study, 5th week
Measurement of System's Usability measured by the therapist
At the end of the study, 5th week
User perception of the device [QUEST 2.0 and QUEST 2.1]
大体时间：At the end of the study, 5th week
QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant
At the end of the study, 5th week
Particpant's stability [Functional Reach Test]
大体时间：At the first day, 3rd week and 5th week
Functional Reach Test
At the first day, 3rd week and 5th week
Systolic/Diastolic Pressure [sphygmomanometer]
大体时间：Before and after the use of the device, during 5 weeks
Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)
Before and after the use of the device, during 5 weeks
Breath Rate [number of breaths per minute]
大体时间：Before and after the use of the device, during 5 weeks
Number of breaths per minute
Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
大体时间：Before and after the use of the device, during 5 weeks
SpO2 measured as %
Before and after the use of the device, during 5 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

MarsiBionics

合作者

Hospital Universitario La Paz

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年10月15日

初级完成 (实际的)

2020年12月31日

研究完成 (实际的)

2021年1月31日

研究注册日期

首次提交

2020年11月3日

首先提交符合 QC 标准的

2021年4月6日

首次发布 (实际的)

2021年4月8日

研究记录更新

最后更新发布 (实际的)

2021年4月8日

上次提交的符合 QC 标准的更新

2021年4月6日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ATLAS2030ENM-I

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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