Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb

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

Status: Completed

Conditions: Prevention of Diseases of the Musculoskeletal System

Treatments: Device: Passive industrial exoskeleton for the upper limb; Other: The protocol will be performed without exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT04514185

PPE-04

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 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.

Full description

This research will recruit 12 volunteers. During a 4-hour laboratory visit, each subject will perform two identical experimental tests: one test without an exoskeleton and another one using the exoskeleton. To avoid sequence bias, the test order will be randomized (balanced). The labor operation will be simulated. This operation's cycle will consist of lifting the load, which is 5-10 kg off the table, holding it over head and touching 4 points in order on a horizontal plate for 2 min. After this volunteer is resting for 1 min. The work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate (Polar) 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: 12 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: None (Open label)

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12 participants in 2 patient groups

With exoskeleton

Experimental group

Description:

The experimental trial will be performed with exoskeleton.

Treatment:

Device: Passive industrial exoskeleton for the upper limb

Without exoskeleton

Experimental group

Description:

The experimental protocol will be performed without exoskeleton.

Treatment:

Other: The protocol will be performed without exoskeleton