跳至主要内容
临床试验/NCT05759650
NCT05759650已完成不适用

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

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Baseline balance and functional mobility

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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).

研究组 & 干预措施

Analyses of Kinematic and Kinetic parameters of movement

Experimental

干预措施: Execution of different motor tasks typical of daily life and work (Other)

结局指标

主要结局

Baseline balance and functional mobility

时间窗: same day of intervention

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

次要结局

  • Joint kinematics data aquisition(same day of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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