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Completed

NCT Number: NCT04514185

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

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.

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Key information

Conditions

Prevention of Diseases of the Musculoskeletal System

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, 105275, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy individuals (based on medical screening)

Exclusion criteria

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

Treatment and study plan

Passive industrial exoskeleton for the upper limb

Device

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

The protocol will be performed without exoskeleton

Other

The protocol will be performed without exoskeleton

Primary outcomes

  1. Heart rate

    Time frame: 4 hours

    A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research

  2. Blood pressure (Systolic and diastolic)

    Time frame: 4 hours

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

  3. Range of motion in large joints of the upper, lower limbs and spine

    Time frame: 1 hour

    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.

  4. Metabolic cost of ergospirometric testing

    Time frame: 4 hours

    A Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities.

  5. Surface electromyography

    Time frame: 1.5 hours

    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.

  6. Myotonometry

    Time frame: 1.5 hours

    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.

  7. Local Comfort Rating Scale

    Time frame: 1 hours

    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.

Secondary outcomes

  1. Exoskeleton parameter evaluation form

    Time frame: 30 minutes

    Questionnaire on partial and general parameters of the exoskeleton and user experience

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2020
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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