Prevention of Diseases of the Musculoskeletal SystemNCT04263220
Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support
A study testing Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back and protocol will be performed without exoskeleton in people with Prevention of Diseases of the Musculoskeletal System, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Diseases of the Musculoskeletal System
- What is being tested?
- Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back and protocol will be performed without exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jan 2020to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals (based on medical screening)
Who cannot join
- musculoskeletal system diseases
- musculoskeletal injuries
- health deviations at the time of the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Moscow, 105275
About this study
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).
- Being tested
- Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back, protocol will be performed without exoskeleton
- Keywords
- industrial exoskeleton, exoskeleton, passive industrial exoskeleton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the backDevice
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
protocol will be performed without exoskeletonOther
protocol will be performed without exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Prototype exoskeleon 1 | Experimental | The experimental trial will be performed with the prototype exoskeleton Receives: Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back |
| Prototype exoskeleon 2 | Experimental | The experimental trial will be performed with the prototype exoskeleton Receives: Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back |
| No exoskeleton | Experimental | The experimental protocol will be performed without exoskeleton. Receives: Other: protocol will be performed without exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Measured: 6 hours
Blood pressure
A Custo med blood pressure monitor will be used by all subjects throughout the study
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start13 Jan 2020
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Diseases of the Musculoskeletal SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized counterbalanced cross-over design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263220
- Sponsor's protocol ID
- PPE-01
- Status last verified
- Jul 2020
- First submitted
- 6 Feb 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support
- ClinicalTrials.gov ID
- NCT04263220
- Acronym / sponsor ID
- PPE-01
- Keywords
- industrial exoskeleton, exoskeleton, passive industrial exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"University, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized counterbalanced cross-over design
| Arm | Type | Receives |
|---|---|---|
| Prototype exoskeleon 1 | Experimental | Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the backThe experimental trial will be performed with the prototype exoskeleton |
| Prototype exoskeleon 2 | Experimental | Device: Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the backThe experimental trial will be performed with the prototype exoskeleton |
| No exoskeleton | Experimental | Other: protocol will be performed without exoskeletonThe experimental protocol will be performed without exoskeleton. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals (based on medical screening)
Key exclusion criteria (3 listed)
- musculoskeletal system diseases
- musculoskeletal injuries
- health deviations at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the backBoth 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 | Device | Prototype exoskeleon 1, Prototype exoskeleon 2 |
| protocol will be performed without exoskeletonprotocol will be performed without exoskeleton | Other | No exoskeleton |
Primary outcome
Heart rate
Time frame: 6 hours
A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Blood pressure
Time frame: 6 hours
A 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 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.
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, 4 hours.
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.
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.
Local Comfort Rating Scale
Time frame: 1 hour
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 secondary outcome
Exoskeleton parameter evaluation form
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back and protocol will be performed without exoskeleton in people with Prevention of Diseases of the Musculoskeletal System, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 6 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.