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

NCT04263220 | Completed

• 1 other identifier: PPE-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Prevention of Diseases of the Musculoskeletal System

Keywords

industrial exoskeleton; exoskeleton; passive industrial exoskeleton

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Exoskeleton parameter evaluation form

  30 minutes

Study Arms (3)

Prototype exoskeleon 1

EXPERIMENTAL

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

Prototype exoskeleon 2

EXPERIMENTAL

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

No exoskeleton

EXPERIMENTAL

The experimental protocol will be performed without exoskeleton.

Other: protocol will be performed without exoskeleton

Interventions

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

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

Prototype exoskeleon 1; Prototype exoskeleon 2

protocol will be performed without exoskeleton OTHER

protocol will be performed without exoskeleton

No exoskeleton

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy individuals (based on medical screening)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, 105275, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding is not possible in this testing set-up, participants however are not informed about the exact purpose of the tests and which exoskeleton is a prototype and which exoskeleton is a commercially available exoskeleton
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey

Model Details: Randomized counterbalanced cross-over design

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: January 13, 2020
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)