- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514172
Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for Back Support
October 8, 2020 updated by: Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
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.
Study Overview
Status
Completed
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).
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Moscow, Russian Federation, 105275
- Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy individuals (based on medical screening)
Exclusion Criteria:
- musculoskeletal system diseases
- musculoskeletal injuries
- health deviations at the time of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: With exoskeleton
The experimental trial will be performed with exoskeleton.
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The goal is to compare the human response to the simulated industrial tasks
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Experimental: Without exoskeleton
The experimental protocol will be performed without exoskeleton.
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The protocol will be performed without exoskeleton
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion in large joints of the upper, lower limbs and spine
Time Frame: 1 hour
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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.
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1 hour
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Metabolic cost of ergospirometric testing
Time Frame: 4 hours
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A Metamax 3B instrument (Cortex, Germany) will be used to measure a metabolic cost during all labor activities, 4 hours.
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4 hours
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Surface electromyography
Time Frame: 1.5 hours
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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.
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1.5 hours
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Myotonometry
Time Frame: 1.5 hours
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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.
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1.5 hours
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Heart rate
Time Frame: 4 hours
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A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
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4 hours
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Blood pressure (Systolic and diastolic)
Time Frame: 4 hours
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A Custo med blood pressure monitor will be used by all subjects throughout the study
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4 hours
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Local Comfort Rating Scale
Time Frame: 1 hours
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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.
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1 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exoskeleton parameter evaluation form
Time Frame: 30 minutes
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Questionnaire on partial and general parameters of the exoskeleton and user experience
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30 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2020
Primary Completion (Actual)
September 5, 2020
Study Completion (Actual)
September 5, 2020
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 9, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PPE-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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