NCT04837144已完成不适用
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
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6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 and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. The protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.The study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. As a secondary outcome, efficacy measurements will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •Weight < 100 kg
- •Height between 1.5 and 1.9 meters
- •Anthropometric measurements to fit in the exoskeleton:
- •Distance from the center of the knee joint to the ground: 42 - 55 cm
- •Distance from the center of the knee to the groin fold: more than 28 cm.
- •Perimeter in thigh (midpoint trochanter - epicondyle): 40 - 63 cm.
- •Perimeter in calf (point of greater volume): 30 - 44 cm.
- •Ability to follow simple commands and communicate basic needs
- •Presence of unilateral hemiparesis
- •Diagnosis of stroke confirmed with imaging tests.
- •Sub-acute or chronic patients (time since diagnosis 1 month or more)
- •Score on FAC scale from 1 to 4
- •Sufficient postural control to maintain standing posture and to take a step with the weight on the affected lower limb, manual assistance or technical aids being allowed
排除标准
- •Spasticity > 3 in lower limbs according to the MAS scale
- •Skin alterations in the contact areas with the exoskeleton
- •Planned surgical intervention during the duration of the study
- •Two or more osteoporotic fractures in the lower limbs in the last 2 years
- •Presence of other pathologies that cause exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, Parkinson's, severe lung disease)
- •Surgical operation in the 3 months prior to the start of the study on the lower limbs
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
- 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)
- Transfers [measured as time to carry out the transfers in seconds](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](at the end of the 5th week)
- Accessibility [number of potential participants in relation with the included participants](at the end of the 5th week)
- Fall Prevalence [number of falls during the using of the device](During the use of the device, for 5 weeks)
- Skin integrity [number of skin injuries related to the device](before and after each use of exoskeleton, for 5 weeks)
- Pain [VAS scale](Before and after the use of the device, during 5 weeks)
- Fatigue [Borg Scale](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)
- Heart rate [measured with sphygmomanometer](Before and after the use of the device, during 5 weeks)
- Physical evaluation [number of physical injuries detected](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)
- ROM [measured with goniometer](At the first day, 3rd week and 5th week)
- Functional Mobility [Functional Ambulation Category scale](At the first day, 3rd week and 5th week)
- System Usability [System Usability Scale](At the 5th week)
- User perception of the device [QUEST 2.0](At the 5th week)
- Distance covered walking [6MWT](At the first day, 3rd week and 5th week)
- Device malfunction [as number and type of device malfunction](During the use of the device, for 5 weeks)
- Particpant's stability [TUG](At the first day, 3rd week and 5th week)
- Breath Rate [Breathings per minute](Before and after the use of the device, during 5 weeks)
- SP/DP [sphygmomanometer](Before and after the use of the device, during 5 weeks)
- SpO2 [pulse oximeter](Before and after the use of the device, during 5 weeks)
研究者
研究点 (2)
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