Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb

NCT ID: NCT04514185

Last Updated: 2020-10-09

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2020-09-26

Brief Summary

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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 lifting and holding weights and having workspace over head on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for upper limb support, a protocol was developed in which individual production operations will be modeled.

Detailed Description

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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's cycle will consist of lifting the load, which is 5-10 kg off the table, holding it over head and touching 4 points in order on a horizontal plate for 2 min. After this volunteer is resting for 1 min. 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).

Conditions

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Prevention of Diseases of the Musculoskeletal System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized counterbalanced cross-over design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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With exoskeleton

The experimental trial will be performed with exoskeleton.

Group Type EXPERIMENTAL

Passive industrial exoskeleton for the upper limb

Intervention Type DEVICE

The goal is to compare the human response to the simulated industrial tasks

Without exoskeleton

The experimental protocol will be performed without exoskeleton.

Group Type EXPERIMENTAL

The protocol will be performed without exoskeleton

Intervention Type OTHER

The protocol will be performed without exoskeleton

Interventions

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Passive industrial exoskeleton for the upper limb

The goal is to compare the human response to the simulated industrial tasks

Intervention Type DEVICE

The protocol will be performed without exoskeleton

The protocol will be performed without exoskeleton

Intervention Type OTHER

Eligibility Criteria

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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

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

OTHER

Sponsor Role lead

Responsible Party

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Andrey Mikhailovich Geregey

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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PPE-04

Identifier Type: -

Identifier Source: org_study_id

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