NCT04837157已完成不适用
Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I
MarsiBionics2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Safety as number of serious device adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Safety as number of serious device adverse events
时间窗: after each use of exoskeleton, for 5 weeks
Presence of a serious device adverse events where the participant or therapist is involved
次要结局
- Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants](At the end of the study, at the 5th week)
- Fall Prevalence [number of falls during the using of the device](During the use of the device, for 5 weeks)
- ROM [measured with goniometer](At the first day, 3rd week and 5th week)
- User perception of the device [QUEST 2.0 and QUEST 2.1](At the end of the study, 5th week)
- Safety as presence of adverse events or adverse device events(after each use of exoskeleton, for 5 weeks)
- Exercises [measured as time per exercise in seconds](after each use of exoskeleton, for 5 weeks)
- Pain [Wong-Baker FACES Pain Rating Scale](Before and after the use of the device, during 5 weeks)
- Fatigue [Borg Rating Scale of Perceived Exertion](Before and after the use of the device, during 5 weeks)
- Spasticity [Modified Ashworth Scale](Before and after the use of the device, during 5 weeks)
- Muscle Strength [measured with Hand Held Dynamometer in N](At the first day, 3rd week and 5th week)
- Distance covered walking [6MWT](At the first day, 3rd week and 5th week)
- SpO2 [pulse oximeter](Before and after the use of the device, during 5 weeks)
- Skin integrity [number of skin injuries related to the device](before and after each use of exoskeleton, for 5 weeks)
- Physical evaluation [number of physical injuries detected](Before and after the use of the device, during 5 weeks)
- Functional Mobility [Functional Ambulation Category scale](At the first day, 3rd week and 5th week)
- System Usability [System Usability Scale](At the end of the study, 5th week)
- Device malfunction [as number and type of device malfunction](During the use of the device, for 5 weeks)
- Particpant's stability [Functional Reach Test](At the first day, 3rd week and 5th week)
- Transfers [measured as time to carry out the transfers in seconds](At each use of exoskeleton, for 5 weeks)
- Accessibility [number of potential participants in relation with the included participants](At the end of the study, at the 5th week)
- Heart rate [sphygmomanometer](Before and after the use of the device, during 5 weeks)
- Systolic/Diastolic Pressure [sphygmomanometer](Before and after the use of the device, during 5 weeks)
- Breath Rate [number of breaths per minute](Before and after the use of the device, during 5 weeks)
研究者
研究点 (2)
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