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

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).

Study Overview

• Status: Completed
• Conditions: Prevention of Diseases of the Musculoskeletal System
• Intervention / Treatment: 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
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105275
    • Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy individuals (based on medical screening)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prototype exoskeleon 1; The experimental trial will be performed with the prototype exoskeleton	Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back; Both exoskeleton types are passive exoskeletons for supporting the back. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions
Experimental: Prototype exoskeleon 2; The experimental trial will be performed with the prototype exoskeleton	Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back; Both exoskeleton types are passive exoskeletons for supporting the back. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions
Experimental: No exoskeleton; The experimental protocol will be performed without exoskeleton.	Other: protocol will be performed without exoskeleton; protocol will be performed without exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research	6 hours
Blood pressure	A Custo med blood pressure monitor will be used by all subjects throughout the study	6 hours
Range of motion in large joints of the upper, lower limbs and spine	Inertial sensors will be mounted on the body of the volunteer. The amplitude of the moving in the shoulder, elbow, hip, knee joints and in the thoracolumbar spine is determined. Flexion and extension, abduction and adduction, rotation are performed.	1 hour
Metabolic cost of ergospirometric testing	A Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities, 4 hours.	4 hours
Surface electromyography	Trust-M sensors with electrodes will be used to collect electromyographic data in accordance with the SENIAM recommendations. The muscles that will be monitored, the muscles of the arms, legs and back, which account for the maximum load. The locations of the sensors will be prepared by shaving, abrasion with sandpaper, and alcohol cleaning. The average amplitude of the EMG spectrum will be collected. The recording will be carried out at rest, standing before and after work, as well as outside work in the voltage position without exoskeleton and with it.	1.5 hours
Myotonometry	Myotonometry will be performed with a Myoton Pro device. Parameters of the certain muscles, which get the maximum load, will be measured at rest standing before and after work, as well as outside work in a stress position without an exoskeleton and with it.	1.5 hours
Local Comfort Rating Scale	This questionnaire is for assessing the duration of maintaining a working posture without discomfort, fixing their appearance, as well as the nature of these sensations. Points can vary from 1 to 10, where 1 is the absence of pain, 10 is unbearable pain.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exoskeleton parameter evaluation form	The questionnaire contains questions related to the operational, ergonomic and aesthetic characteristics of the exoskeleton. The assessment will be carried out in points on a scale from -2 to +2.	30 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: exoskeleton; industrial exoskeleton; passive industrial exoskeleton
• Other Study ID Numbers: PPE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No