The Effect of a Novel Passive Shoulder Exoskeleton During Industrial Work

NCT ID: NCT04105101

Last Updated: 2021-04-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2022-09-30

Brief Summary

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After designing a first prototype of next generation industrial exoskeleton, the system should be evaluated in laboratory conditions. In order to evaluate the passive shoulder exoskeleton, designed to assist workers, a protocol is developed in which parts of industrial work is simulated. The results of this evaluation will serve as input for the next iterative design process/cycle of the prototype.

In this study 15 subjects will be recruited. During a 3.5h lab visit, each subject will perform three identical experimental trials; one trial without exoskeleton, one trial with a commercially available exoskeleton and one with the newly developed prototype. To avoid sequence bias, the order of the trials will be randomized (counterbalanced). The protocol consists of 6 tasks, always performed in the same sequence; lifting 5 kg 5 times from hip height to overhead height, completing a wiring task overhead (90 sec), 6 minutes walking, 6 min lifting from hip to overhead height (10 kg), 6 min lifting from ground to hip level (10 kg) and drilling for 30 sec with a force of 60N (±20 N). Before each task, 5 min of rest will be provided, and the subject will receive 10 min of rest in between different experimental trials. Electrocardiographic data, chest expansion and skin temperature will be monitored through a belt (Equivital, AD Instruments). An ergospirometric device (K5, Cosmed) will be used to gather gas exchange data, and (non-invasive) EMG electrodes will be applied to collect muscle activity data during the trials (Cometa). IMUs will be applied to the subjects' extremities to analyse the movement pattern (Technaid). Furthermore, questionnaires will be filled out to assess the subjective experience (Rating of Perceived Exertion, Sustained Usability Scale, Local Discomfort Scale).

Detailed Description

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Conditions

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Exoskeleton Device

Study Design

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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

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Prototype exoskeleon

The experimental trial will be performed with the prototype exoskeleton

Group Type EXPERIMENTAL

Industrial passive shoulder exoskeleton

Intervention Type DEVICE

Both exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions.

Skel-Ex

The experimental protocol will be performed with the commercially available Skel-Ex 360 (Skel-Ex, Rotterdam, The Netherlands)

Group Type EXPERIMENTAL

Industrial passive shoulder exoskeleton

Intervention Type DEVICE

Both exoskeleton types are passive shoulder exoskeletons. 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

Industrial passive shoulder exoskeleton

Intervention Type DEVICE

Both exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions.

Interventions

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Industrial passive shoulder exoskeleton

Both exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy individuals (based on ParQ questionnaire)

Exclusion Criteria

* work related disorders
* shoulder injuries in the past
* back injuries in the past
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Romain Meeusen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Romain Meeusen, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

VUB

Locations

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Lichamelijk Opvoeding en Kinesitherapie

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EXOTEST2019

Identifier Type: -

Identifier Source: org_study_id

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