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

NCT ID: NCT04263220

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2020-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of Diseases of the Musculoskeletal System

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized counterbalanced cross-over design
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Blinding is not possible in this testing set-up, participants however are not informed about the exact purpose of the tests and which exoskeleton is a prototype and which exoskeleton is a commercially available exoskeleton

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prototype exoskeleon 1

The experimental trial will be performed with the prototype exoskeleton

Group Type EXPERIMENTAL

Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back

Intervention Type DEVICE

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

Prototype exoskeleon 2

The experimental trial will be performed with the prototype exoskeleton

Group Type EXPERIMENTAL

Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back

Intervention Type DEVICE

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

No exoskeleton

The experimental protocol will be performed without exoskeleton.

Group Type EXPERIMENTAL

protocol will be performed without exoskeleton

Intervention Type OTHER

protocol will be performed without exoskeleton

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

protocol will be performed without exoskeleton

protocol will be performed without exoskeleton

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy individuals (based on medical screening)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrey Mikhailovich Geregey

Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PPE-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.