Clinical trial NCT04514185: Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb
Official title: Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb
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: 2020-08-14
Enrollment: 12
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 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.

Detailed 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).

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: 4 hours
measure: Blood pressure (Systolic and diastolic)
timeFrame: 4 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 hours
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: