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

Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

Status: Completed

Conditions: Prevention of Diseases of the Musculoskeletal System

Treatments: Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back; Other: protocol will be performed without exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT04263220

PPE-01

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy individuals (based on medical screening)

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 3 patient groups

Prototype exoskeleon 1

Experimental group

Description:

The experimental trial will be performed with the prototype exoskeleton

Treatment:

Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back

Prototype exoskeleon 2

Experimental group

Description:

The experimental trial will be performed with the prototype exoskeleton

Treatment:

Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back

No exoskeleton

Experimental group

Description:

The experimental protocol will be performed without exoskeleton.

Treatment:

Other: protocol will be performed without exoskeleton