Prevention of Diseases of the Musculoskeletal System Clinical Trial
Official title:
Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb
NCT number | NCT04514185 |
Other study ID # | PPE-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 22, 2020 |
Est. completion date | September 26, 2020 |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 26, 2020 |
Est. primary completion date | September 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - healthy individuals (based on medical screening) Exclusion Criteria: - musculoskeletal system diseases - musculoskeletal injuries - health deviations at the time of the study |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate | A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research | 4 hours | |
Primary | Blood pressure (Systolic and diastolic) | A Custo med blood pressure monitor will be used by all subjects throughout the study | 4 hours | |
Primary | Range of motion in large joints of the upper, lower limbs and spine | 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. | 1 hour | |
Primary | Metabolic cost of ergospirometric testing | A Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities. | 4 hours | |
Primary | Surface electromyography | 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. | 1.5 hours | |
Primary | Myotonometry | 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. | 1.5 hours | |
Primary | Local Comfort Rating Scale | 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. | 1 hours | |
Secondary | Exoskeleton parameter evaluation form | Questionnaire on partial and general parameters of the exoskeleton and user experience | 30 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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