Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Blood pressure (Systolic and diastolic)
研究概览
简要总结
This research will provide data on evaluation of the effectiveness and safety of using a passive exoskeleton designed to reduce the negative impact of static and dynamic loads associated with lifting and holding weights and having workspace over head on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for upper limb support, a protocol was developed in which individual production operations will be modeled.
详细描述
This research will recruit 12 volunteers. During a 4-hour laboratory visit, each subject will perform two identical experimental tests: one test without an exoskeleton and another one using the exoskeleton. To avoid sequence bias, the test order will be randomized (balanced). The labor operation will be simulated. This operation's cycle will consist of lifting the load, which is 5-10 kg off the table, holding it over head and touching 4 points in order on a horizontal plate for 2 min. After this volunteer is resting for 1 min. The work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate (Polar) will be monitored. An ergospirometric device (Metamax) will be used to collect muscle activity data (Trust-M, Myoton), inertial sensors (Trust-M) will be used to evaluate the biomechanics of movements. In addition, questionnaires will be filled out for a subjective assessment of the use of exoskeleton prototypes (local discomfort scale, exoskeleton properties assessment questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy individuals (based on medical screening)
排除标准
- •musculoskeletal system diseases
- •musculoskeletal injuries
- •health deviations at the time of the study
结局指标
主要结局
Blood pressure (Systolic and diastolic)
时间窗: 4 hours
A Custo med blood pressure monitor will be used by all subjects throughout the study
Range of motion in large joints of the upper, lower limbs and spine
时间窗: 1 hour
Inertial sensors will be mounted on the body of the volunteer. The amplitude of the moving in the shoulder, elbow, hip, knee joints and in the thoracolumbar spine is determined. Flexion and extension, abduction and adduction, rotation are performed.
Surface electromyography
时间窗: 1.5 hours
Trust-M sensors with electrodes will be used to collect electromyographic data in accordance with the SENIAM recommendations. The muscles that will be monitored, the muscles of the arms, legs and back, which account for the maximum load. The locations of the sensors will be prepared by shaving, abrasion with sandpaper, and alcohol cleaning. The average amplitude of the EMG spectrum will be collected. The recording will be carried out at rest, standing before and after work, as well as outside work in the voltage position without exoskeleton and with it.
Local Comfort Rating Scale
时间窗: 1 hours
This questionnaire is for assessing the duration of maintaining a working posture without discomfort, fixing their appearance, as well as the nature of these sensations. Points can vary from 1 to 10, where 1 is the absence of pain, 10 is unbearable pain.
Heart rate
时间窗: 4 hours
A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Metabolic cost of ergospirometric testing
时间窗: 4 hours
A Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities.
Myotonometry
时间窗: 1.5 hours
Myotonometry will be performed with a Myoton Pro device. Parameters of the certain muscles, which get the maximum load, will be measured at rest standing before and after work, as well as outside work in a stress position without an exoskeleton and with it.
次要结局
- Exoskeleton parameter evaluation form(30 minutes)
研究者
Andrey Mikhailovich Geregey
Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey
Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"