Clinical trial NCT05385328: Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations
Official title: Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations (EYEFUL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Handicaps Physical
Fetal Alcohol Syndrome
Mental Disability
Keywords: Activities of Daily Life
Clinical evaluation
Multisensorial analysis
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: AlcaládeHenaresU
First posted: 2022-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The control group sample will be obtained by convenience, through the contacts of the research group and the university environment. In turn, a group of subjects with a medical diagnosis will be selected from the Hospital Universitario Fundación Alcorcón and the Hospital Universitario Ramón y Cajal of the Community of Madrid.

Brief summary: Physical and cognitive changes provoked by a pathology worsen the functional capability of the individual making it more difficult to perform Activities of Daily Living (ADLs) and causing dependency and/or disability. There are standardized observational tests for the clinical assessment of the degree of functional limitation in basic or instrumental ADLs (e.g., Assessment Motor and Process Skills - AMPS). On the other hand, all these tests bear the problem of the subjectivity of the evaluator in the analysis. The presence of the evaluator in the test may have an influence in the way a subject performs ADLs.

The goal of the project is to develop a methodology to design, implement and validate automatic clinical tests of functional limitation, that: 1) give objective assessments with clinical validity, and 2) remove the interference in the test execution caused by the physical presence of the evaluator.

Detailed description: Physical and cognitive changes provoked by a pathology worsen the functional capability of the individual making it more difficult to perform Activities of Daily Living (ADLs) and causing dependency and/or disability. There are standardized observational tests for the clinical assessment of the degree of functional limitation in basic or instrumental ADLs (e.g., Assessment Motor and Process Skills - AMPS). On the other hand, all these tests bear the problem of the subjectivity of the evaluator in the analysis. The presence of the evaluator in the test may have an influence in the way a subject performs ADLs.

The goal of the project is to develop a methodology to design, implement and validate automatic clinical tests of functional limitation, that: 1) give objective assessments with clinical validity, and 2) remove the interference in the test execution caused by the physical presence of the evaluator. The human evaluator subjectivity will be replaced with an automatic system that extracts multimodal (i.e., multisensorial) information from the environment during the user functional assessment. Specifically including audio, video and depth sensors and the information collected from wearable sensors that the subject under test may carry. The objective assessment will also provide clues that, given the subject clinical history, can be used for early detection of limitations.

This problem has not been systematically addressed in the literature. The project is thus a first solution of the development and clinical validation of an automated system that allows an objective evaluation of observational tests. Tackling the clinical assessment of functional limitations will be then performed in an adapted real environment (equipped with the adequate electronic sensors) in the URJC facilities.

The EYEFUL-URJC subproject has a key role in the methodological design and clinical validation of the automatic evaluation tools. They will also carry out the actual tests over normal subjects and patients comparing the output of the current tools, as AMPS, with the output of the assessment tools developed for the project. In order to extract relevant features from video, depth, audio and other sensors, the project leverages the research experience on automatic sensing of human activities in intelligent spaces of EYEFUL-UPM and EYEFUL-UAH. The EYEFUL-UPM subproject concentrates in the analysis of the subject face, head pose, gaze, and accurate 3D alignment of the facial landmarks, that enable the estimation facial attributes useful for different tests (i.e., focus of attention, presence of pain, confusion, fear, etc.). The EYEFUL-UAH subproject concentrates the analysis on the user whole body activity and her/his interaction with objects, with depth and video sensors, and integrating also audio and wearables' data to automatically assess the functional capability of the evaluated persons. The three coordinated groups approach the project in an interdisciplinary way, with strong feedback requirements among them all along the development. This close interaction is fundamental to ensure the adequate focus of the technical developments given the strict clinical requirements of the task.

Eligibility criteria: Inclusion criteria:

* People with a Certificate of Disability from the Ministry of Health, Consumer Affairs and Welfare.
* Degree of disability (percentage from 0-90%, where 100% reflects the maximum disability)
* over 18 years of age.

Exclusion criteria:

* Inability to follow-2-step commands.
* If participant is unwilling to travel for assessment.
* Currently in treatment with: Psychotropics, Antipsychotics and/or Benzodiazepines.
* People with a Certificate of Disability from the Ministry of Health, Consumer Affairs and Welfare.
* Degree of disability (percentage of 90-100%, where 100% reflects the maximum disability)
* Refusal to sign the informed consent form.

Primary outcomes:
measure: Physical measures
timeFrame: Frist year
measure: Physical measures 2
timeFrame: Frist year
measure: Accelerometry
timeFrame: Frist year
measure: Accelerometry 2
timeFrame: Frist year
measure: Accelerometry 3
timeFrame: Frist year
measure: Facial expression
timeFrame: second year
measure: Quality of performance
timeFrame: second year
measure: Functional ability
timeFrame: second year
measure: Severity of anxiety and depression
timeFrame: second year
measure: Self-perception of performance
timeFrame: second year
measure: Functional cognitive performance
timeFrame: second year
measure: Cognitive processing
timeFrame: second year
measure: Degree of disability and quality of life
timeFrame: second year
measure: Analytical validation
timeFrame: Third year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad Ciencias de la Salud. Universidad Rey Juan Carlos
state: Alcorcón
Study officials:
References: