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

Prevention of Diseases of the Musculoskeletal System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263220
• Other study ID #: PPE-01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: March 20, 2020

Study information

• Verified date: July 2020
• Source: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy individuals (based on medical screening)

Exclusion Criteria:

• musculoskeletal system diseases

• musculoskeletal injuries

• health deviations at the time of the study

Related Conditions & MeSH terms

• Prevention of Diseases of the Musculoskeletal System

Intervention

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

Other:
• protocol will be performed without exoskeleton
protocol will be performed without exoskeleton

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research	6 hours
Primary	Blood pressure	A Custo med blood pressure monitor will be used by all subjects throughout the study	6 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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