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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Execution of different motor tasks typical of daily life and work
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Istituto Auxologico Italiano IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Analyses of Kinematic and Kinetic parameters of movement

Arm Description

Outcomes

Primary Outcome Measures

Baseline balance and functional mobility
Measurement of balance and functional mobility using Timed Up and Go test (TUG) at baseline.

Secondary Outcome Measures

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.

Full Information

First Posted
February 26, 2023
Last Updated
February 26, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05759650
Brief Title
Analysis of Functional Performance in Subjects With Obesity During Motor Tasks.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Analyses of Kinematic and Kinetic parameters of movement
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Execution of different motor tasks typical of daily life and work
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline balance and functional mobility
Description
Measurement of balance and functional mobility using Timed Up and Go test (TUG) at baseline.
Time Frame
same day of intervention
Secondary Outcome Measure Information:
Title
Joint kinematics data aquisition
Description
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.
Time Frame
same day of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Cimolin, PhD
Organizational Affiliation
Politecnico di Milano
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Oggebbio
State/Province
VB
ZIP/Postal Code
28824
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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