Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05777304
Other study ID # 2475
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2010
Est. completion date May 6, 2022

Study information

Verified date December 2023
Source Istituti Clinici Scientifici Maugeri SpA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 6, 2022
Est. primary completion date January 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - healthy subjects Exclusion Criteria: - subjects with musculoskeletal pathologies or other disabling pathologies in progress

Study Design


Related Conditions & MeSH terms


Intervention

Device:
wearable device
IMU sensors and EMG sensors

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istituti Clinici Scientifici Maugeri SpA

References & Publications (4)

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. — View Citation

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. — View Citation

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 — View Citation

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/diagnostics12123 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of the proposed strategy to assess the risk of lifting activities, according to RNLE accuracy degree and AucRoc first year
See also
  Status Clinical Trial Phase
Completed NCT04444453 - Early Ambulation to Reduce Hospital Length of Stay N/A
Recruiting NCT05636930 - Accuracy Assessment of Sleep Monitoring Technology
Active, not recruiting NCT05719129 - The Lasting Change Study
Withdrawn NCT05887518 - The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism N/A