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

NCT05759650 | Completed

• 1 other identifier: 31C211
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Joint kinematics data aquisition

  same day of intervention

Study Arms (1)

Analyses of Kinematic and Kinetic parameters of movement

EXPERIMENTAL

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

Interventions

Execution of different motor tasks typical of daily life and work OTHER

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.

Analyses of Kinematic and Kinetic parameters of movement

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>= 30/35 Kg/m2;
• No impediments to physical activity;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Oggebbio, VB, 28824, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica Cimolin, PhD

  Politecnico di Milano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: September 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-02

Locations

IT (1)