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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04514172
Enrollment
12
Registered
2020-08-14
Start date
2020-07-22
Completion date
2020-09-05
Last updated
2020-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Diseases of the Musculoskeletal System

Keywords

industrial exoskeleton, exoskeleton, passive industrial exoskeleton

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.

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 will consist of lifting the load, which is 20 kg off the floor, walking 1.5m to a surface with a height of 70 cm to put it on, the frequency of lifting is 1 time in 30 seconds. 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).

Interventions

DEVICEPassive industrial exoskeleton for back support

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

The protocol will be performed without exoskeleton

Sponsors

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized counterbalanced cross-over design

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy individuals (based on medical screening)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Local Comfort Rating Scale1 hoursThis 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.
Heart rate4 hoursA Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Blood pressure (Systolic and diastolic)4 hoursA Custo med blood pressure monitor will be used by all subjects throughout the study
Range of motion in large joints of the upper, lower limbs and spine1 hourInertial 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.
Metabolic cost of ergospirometric testing4 hoursA Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities, 4 hours.
Surface electromyography1.5 hoursTrust-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.
Myotonometry1.5 hoursMyotonometry 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.

Secondary

MeasureTime frameDescription
Exoskeleton parameter evaluation form30 minutesQuestionnaire on partial and general parameters of the exoskeleton and user experience

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026