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Trials / Completed

CompletedNCT05759650

Analysis of Functional Performance in Subjects With Obesity During Motor Tasks.

Validation of an Integrated Assessment Protocol for the Analysis of Functional Performance in Subjects With Obesity During Motor Tasks Associated With Daily and Work Activities. Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Istituto Auxologico Italiano · Academic / Other
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Background. Individuals with obesity can present several functional limitations that can significantly impact on their quality of life. Furthermore, even during the execution of specific motor tasks, subjects with obesity can experience excessive biomechanical overload. It is therefore necessary to develop appropriate assessment protocols that are able to provide support for risk assessment, in consideration of different types of motor tasks, including movements that can reflect the main daily and / or work activities. In this perspective, it is essential to define a protocol that includes an integrated evaluation process based on objective and quantitative metrics, i.e., functional scales, clinical scores, etc. In this context, the quantitative analysis of movement is widely used in clinical practice and in research to investigate in an objective and comprehensive way on movement disorders in various pathological conditions, including obesity. Conventionally, kinematic and kinetic parameters of movement are measured in motion analysis laboratories, using optoelectronic systems based on passive markers, force platforms and electromyographic systems, which represent the gold standard. Although motion analysis is considered accurate, the availability of specific laboratories, high costs and dependence on trained users sometimes limit its use in clinical practice. A variety of wearable sensors available today has enabled researchers and clinicians to pursue applications where individuals are monitored in home and outpatient settings. Hypothesis and significance. The hypothesis is that wearables could reveal a good agreement, accuracy, and correlation between the parameters measured by means of optoelectronic system and those measured by wearables in individuals with obesity. Specific Aims. The main objective is the implementation of an integrated protocol for the clinical evaluation of subjects with obesity through the analysis of the execution of different motor tasks typical of daily life and work. Appropriately identified clinical scores and scales will also be supported by quantitative evaluations carried out with human movement analysis systems (optoelectronic systems based on markers and inertial measurement units).

Conditions

Interventions

TypeNameDescription
OTHERExecution of different motor tasks typical of daily life and workPatients with obesity will carry out different motor tasks typical of daily life and work and, using optoelectronic systems based on passive markers, force platforms and electromyographic systems, kinematic and kinetic parameters of movement will be recorded and analysed for the implementation of an integrated protocol for the clinical evaluation of subjects with obesity.

Timeline

Start date
2022-09-01
Primary completion
2022-11-30
Completion
2022-11-30
First posted
2023-03-08
Last updated
2023-03-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05759650. Inclusion in this directory is not an endorsement.