Clinical trial NCT04263220: Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support
Official title: Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Diseases of the Musculoskeletal System
Keywords: industrial exoskeleton
exoskeleton
passive industrial exoskeleton
Lead sponsor: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized counterbalanced cross-over design
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* musculoskeletal system diseases
* musculoskeletal injuries
* health deviations at the time of the study

Primary outcomes:
measure: Heart rate
timeFrame: 6 hours
measure: Blood pressure
timeFrame: 6 hours
measure: Range of motion in large joints of the upper, lower limbs and spine
timeFrame: 1 hour
measure: Metabolic cost of ergospirometric testing
timeFrame: 4 hours
measure: Surface electromyography
timeFrame: 1.5 hours
measure: Myotonometry
timeFrame: 1.5 hours
measure: Local Comfort Rating Scale
timeFrame: 1 hour
Secondary outcomes:
measure: Exoskeleton parameter evaluation form
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Study officials:
References: