- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777304
Wearable Sensors and Machine Learning for the Assessment of Biomechanical Risk in Lifting Tasks
December 21, 2023 updated by: Edda Capodaglio, Istituti Clinici Scientifici Maugeri SpA
Wearable Sensors and Machine Learning: a Technological Approach to Biomechanical Risk Assessment in Lifting Tasks
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.
Study Overview
Detailed Description
The study envisages the voluntary enrollment of healthy subjects, referring to treatment clinics for work-related pathologies (excluding subjects aged <18 or > 65 years, and those with musculoskeletal pathologies or other disabling pathologies in progress), to carry out two repeated lifting tests.
The two tests are set up to correspond respectively to the two NIOSH risk classes (LI<1, NO RISK; and LI>1, RISK).
The IMU sensors provide wirelessly a series of data from which it is intended to extract a number of features (feature extraction) that have a high predictive power, through the digital signal processing technique using dedicated software (i.e.
Matlab, SPSS).
In a second step, data obtained from EMG sensors will be added to the analysis.
Among the different artificial intelligence algorithms, the investigator will look for those most able to discriminate the various risk classes on the basis of the parameters extracted from the signals detected during the motor task.
Study Type
Observational
Enrollment (Actual)
41
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
healthy volunteer referring to treatment clinics for work-related pathologies
Description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- subjects with musculoskeletal pathologies or other disabling pathologies in progress
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of the proposed strategy to assess the risk of lifting activities, according to RNLE
Time Frame: first year
|
accuracy degree and AucRoc
|
first year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edda Capodaglio, PhD, ICS Maugeri IRCCS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2010
Primary Completion (Actual)
January 24, 2022
Study Completion (Actual)
May 6, 2022
Study Registration Dates
First Submitted
March 2, 2023
First Submitted That Met QC Criteria
March 17, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Actual)
December 28, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.