Clinical trial NCT04105101: The Effect of a Novel Passive Shoulder Exoskeleton During Industrial Work
Official title: The Effect of a Novel Passive Shoulder Exoskeleton on the Human Body During Simulated Industrial Tasks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exoskeleton Device
Keywords: Human-centered robotics
Prototype evaluation
Industry
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized counterbalanced cross-over design
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* healthy individuals (based on ParQ questionnaire)

Exclusion Criteria:

* work related disorders
* shoulder injuries in the past
* back injuries in the past

Primary outcomes:
measure: Surface electromyography
timeFrame: Electromyographic data will be collected continuously during all simulated industrial tasks. This will take 3 hours in total.
measure: Heart rate
timeFrame: Heart rate will be monitored continuously during all tasks. This will take 3 hours in total
measure: Metabolic cost
timeFrame: Metabolic cost will be monitored continuously during all tasks. This will take 3 hours in total
measure: session Rating of Perceived exertion
timeFrame: the sRPE will be asked at the end of the task. The entire protocol will last for approximately 3 hours.
Secondary outcomes:
measure: Heart rate variability
timeFrame: Will be computed for every task. The recording will be continuous throughout the whole protocol, lasting for approximately 3 hours.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Lichamelijk Opvoeding en Kinesitherapie
Study officials:
affiliation: VUB
name: Romain Meeusen, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: