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

Obesity Clinical Trial

— Obesity_TASK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05759650
• Other study ID #: 31C211
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI >= 30/35 Kg/m2;

• No impediments to physical activity;

Exclusion Criteria:

• Pathologies of the locomotor system,

• Neurological pathologies affecting movement;

• Internal pathologies contraindicating physical activity;

• Pregnant or breastfeeding women;

• Individuals with genetic obesity (Down's or Prader-Willi syndrome).

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Execution of different motor tasks typical of daily life and work
Patients 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.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Oggebbio	VB

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline balance and functional mobility	Measurement of balance and functional mobility using Timed Up and Go test (TUG) at baseline.	same day of intervention
Secondary	Joint kinematics data aquisition	Joint kinematics data deriving from the use of optoelectronic systems and inertial measurement units will be collected, including trunk angles during flexion movement, axial rotation bending, upper limb flexion angle during lateral lift and angle on the frontal plane of the upper limb during front lift.	same day of intervention