NCT05389384

Brief Summary

In this investigation, participants perform simulated occupational work during which the task performance will be logged. This research investigates the effect of peripheral fatigue and a passive shoulder exoskeleton on the task performance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

April 26, 2021

Last Update Submit

May 19, 2022

Conditions

FatigueMuscle StrainPhysical Stress

Keywords

peripheral fatigueoverhead worktask performanceergonomicseffort

Outcome Measures

Primary Outcomes (2)

  • Work accuracy

    The number of errors is tracked

    During 2 minutes overhead work

  • Work pace

    Time to completion is tracked

    During 2 minutes overhead work

Secondary Outcomes (3)

  • Surface electromyography

    During 2 minutes overhead work

  • Kinematic smoothness of movement

    During 2 minutes overhead work

  • Workload

    After 2 minutes of overhead work

Other Outcomes (1)

  • Force output

    before and after 4 minute during fatigue inducing protocol

Study Arms (4)

Peripheral fatigue - No support

EXPERIMENTAL

peripheral fatigue induced and overhead work performed without exoskeleton support

Behavioral: Fatigue protocolDevice: No exoskeleton support

Peripheral fatigue - Exoskeleton support

EXPERIMENTAL

peripheral fatigue induced and overhead work performed with exoskeleton support

Device: Passive shoulder exoskeletonBehavioral: Fatigue protocol

No fatigue - No support

EXPERIMENTAL

peripheral fatigue induced and overhead work performed without exoskeleton support

Device: No exoskeleton supportBehavioral: No peripheral fatiguing protocol

No fatigue - Exoskeleton support

EXPERIMENTAL

peripheral fatigue induced and overhead work performed with exoskeleton support

Device: Passive shoulder exoskeletonBehavioral: No peripheral fatiguing protocol

Interventions

Passive shoulder exoskeletonDEVICE

Participants complete overhead working task with support of exo

No fatigue - Exoskeleton supportPeripheral fatigue - Exoskeleton support
Fatigue protocolBEHAVIORAL

Participants complete a fatiguing protocol

Peripheral fatigue - Exoskeleton supportPeripheral fatigue - No support
No exoskeleton supportDEVICE

Exoskeleton is worn, but no support provided

No fatigue - No supportPeripheral fatigue - No support
No peripheral fatiguing protocolBEHAVIORAL

Participants complete no fatiguing protocol

No fatigue - Exoskeleton supportNo fatigue - No support

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy (based on ParQ questionnaire)
  • right handed

You may not qualify if:

  • current musculoskeletal disorder
  • history of recurrent musculoskeletal discorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lichamelijk Opvoeding en Kinesitherapie

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

FatigueSprains and Strains

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Romain Meeusen, PhD

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The support of the exoskeleton is concealed. The support will be 'no support' or 'support'.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: counterbalanced randomized cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 25, 2022

Study Start

August 20, 2021

Primary Completion

July 31, 2022

Study Completion

December 31, 2023

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Data will be published in scientific journal. No IPD will be published.

Locations

BE(1)