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

NCT04514185 | Completed

• 1 other identifier: PPE-04
• Study Type: interventional
• Target: 12
• 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 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.

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

  4 hours

• Blood pressure (Systolic and diastolic)

  A Custo med blood pressure monitor will be used by all subjects throughout the study

  4 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

• 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 hours

Secondary Outcomes (1)

• Exoskeleton parameter evaluation form

  30 minutes

Study Arms (2)

With exoskeleton

EXPERIMENTAL

The experimental trial will be performed with exoskeleton.

Device: Passive industrial exoskeleton for the upper limb

Without exoskeleton

EXPERIMENTAL

The experimental protocol will be performed without exoskeleton.

Other: The protocol will be performed without exoskeleton

Interventions

Passive industrial exoskeleton for the upper limb DEVICE

The goal is to compare the human response to the simulated industrial tasks

With exoskeleton

The protocol will be performed without exoskeleton OTHER

The protocol will be performed without exoskeleton

Without 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: NONE
• 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: August 11, 2020
• First Posted: August 14, 2020
• Study Start: July 22, 2020
• Primary Completion: September 26, 2020
• Study Completion: September 26, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)