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

Study Overview
=================
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).

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

Conditions
-----------------
Prevention of Diseases of the Musculoskeletal System

Intervention / Treatment
-----------------
* Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back
* Other: protocol will be performed without exoskeleton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals (based on medical screening) Exclusion Criteria: musculoskeletal system diseases musculoskeletal injuries health deviations at the time of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized counterbalanced cross-over design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype exoskeleon 1<br>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<br>* 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<br>|
| Experimental: Prototype exoskeleon 2<br>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<br>* 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<br>|
| Experimental: No exoskeleton<br>The experimental protocol will be performed without exoskeleton. | Other: protocol will be performed without exoskeleton<br>* protocol will be performed without exoskeleton<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
industrial exoskeleton, exoskeleton, passive industrial exoskeleton