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Clinical Trial Summary

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 body tilts, lifting and holding weights on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for back support, a protocol was developed in which individual production operations will be modeled.

This research will recruit 9 valunteers. During a 4-hour laboratory visit, each subject will perform three identical experimental tests: one test without an exoskeleton and two tests using two different modifications of the exoskeleton prototype. To avoid sequence bias, the test order will be randomized (balanced). Two types of labor operations will be simulated. One operation will consist in lifting the load, which is 20% of the volunteer's body weight, from a height of 14 cm to a surface with a height of 70 cm, the frequency of lifting is 1 time in 30 seconds. The second operation is holding a cargo weighing 5 kg in a forced working position (tilt of the body more than 30 °) for 1 minute, after which rest will follow for 1 minute, and then the work will be repeated. Both types of work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate, blood pressure, ECG (Custo) 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Prevention of Diseases of the Musculoskeletal System

NCT number NCT04263220
Study type Interventional
Source Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
Contact
Status Completed
Phase N/A
Start date January 13, 2020
Completion date March 20, 2020

See also
  Status Clinical Trial Phase
Completed NCT04514172 - Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for Back Support N/A
Completed NCT04514185 - Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb N/A