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Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support

NCT04263220 · Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" · Updated 28 July 2020

What is being tested
Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back; protocol will be performed without exoskeleton
For
Prevention of Diseases of the Musculoskeletal System
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 45 years. About 9 people. The full rules are on the registry page.
Where
Russia
When
Starts or started 13 Jan 2020, ends 20 March 2020. Registered 10 Feb 2020.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT04263220

Sites

  • Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational HealthMoscow, Russia