NCT05777304

Brief Summary

Lifting loads can cause work-related musculoskeletal disorders. The National Institute for Occupational Safety and Health (NIOSH) established a methodology for assessing lifting actions by means of a quantitative method based on intensity, duration, frequency, and other geometrical characteristics of lifting. Body-worn inertial sensor technology provides a number of opportunities to advance the safety and health of workers engaged in physical work. Motion-tracking systems together with Machine learning (ML) algorithms are used in the ergonomic field for biomechanical risk assessment by means of data acquired by wearable inertial systems. The investigators posed the question whether it is possible to classify lifting tasks belonging to different risk classes according to the value of LI using a machine learning approach by means of features extracted from raw signals. Aim of this study was to develop and validate, through ML algorithms, a non-invasive detection system of kinetic-kinematic parameters using IMU and EMG sensors, for the ergonomic assessment of the risk associated with a load lifting activity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

October 7, 2010

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

11.3 years

First QC Date

March 2, 2023

Last Update Submit

December 21, 2023

Conditions

Keywords

inertial measurement unitsAccelerometersErgonomicsExposure assessmentLiftingWork-related musculoskeletal disordersMachine learningDigital signal processingRisk prediction

Outcome Measures

Primary Outcomes (1)

  • Validation of the proposed strategy to assess the risk of lifting activities, according to RNLE

    accuracy degree and AucRoc

    first year

Interventions

IMU sensors and EMG sensors

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteer referring to treatment clinics for work-related pathologies

You may qualify if:

  • healthy subjects

You may not qualify if:

  • subjects with musculoskeletal pathologies or other disabling pathologies in progress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Donisi L, Cesarelli G, Capodaglio E, Panigazzi M, D'Addio G, Cesarelli M, Amato F. A Logistic Regression Model for Biomechanical Risk Classification in Lifting Tasks. Diagnostics (Basel). 2022 Oct 29;12(11):2624. doi: 10.3390/diagnostics12112624.

  • Donisi L, Cesarelli G, Pisani N, Ponsiglione AM, Ricciardi C, Capodaglio E. Wearable Sensors and Artificial Intelligence for Physical Ergonomics: A Systematic Review of Literature. Diagnostics (Basel). 2022 Dec 5;12(12):3048. doi: 10.3390/diagnostics12123048.

  • Donisi L, Capodaglio EM, Amitrano F, Cesarelli G, Pagano G, D'Addio G. A multiple linear regression approach to extimate lifted load from features extracted from inertial data. G Ital Med Lav Ergon. 2021 Dec;43(4):373-378.

  • Donisi L, Cesarelli G, Coccia A, Panigazzi M, Capodaglio EM, D'Addio G. Work-Related Risk Assessment According to the Revised NIOSH Lifting Equation: A Preliminary Study Using a Wearable Inertial Sensor and Machine Learning. Sensors (Basel). 2021 Apr 7;21(8):2593. doi: 10.3390/s21082593.

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Edda Capodaglio, PhD

    ICS Maugeri IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 21, 2023

Study Start

October 7, 2010

Primary Completion

January 24, 2022

Study Completion

May 6, 2022

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share