Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations

Fetal Alcohol Syndrome Clinical Trial

— EYEFUL  

Official title:

Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations (EYEFUL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385328
• Other study ID #: KingJuanCarlosU
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2022
• Source: Universidad Rey Juan Carlos
• Contact: Marta Pérez-de-Heredia-Torres
• Phone: 34914888886
• Email: marta.perezdeheredia[@]urjc.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Handicaps Physical

Intervention

Device:
• EYEFUL: healthy people
This kind of study implies that we do not require the use of any substance, medicine or therapeutic technique and neither imply any risk to the participants. The data to be captured are exclusively video and audio recordings, and different signals from smart watches (mainly related to movement). Addittionaly, the clinical evaluation of the performance of these activities will be carried out according to the assessment scales to be defined in the project. The results of this evaluation will be exclusively used in the training of the automatic systems developed in the project and in order to establish a correlation between the captured observations (video, audio, smart watches signals) and the diagnostic assessment.
• EYEFUL: people with pathology
This kind of study implies that we do not require the use of any substance, medicine or therapeutic technique and neither imply any risk to the participants. The data to be captured are exclusively video and audio recordings, and different signals from smart watches (mainly related to movement). Addittionaly, the clinical evaluation of the performance of these activities will be carried out according to the assessment scales to be defined in the project. The results of this evaluation will be exclusively used in the training of the automatic systems developed in the project and in order to establish a correlation between the captured observations (video, audio, smart watches signals) and the diagnostic assessment.

Locations

Country	Name	City	State
Spain	Facultad Ciencias de la Salud. Universidad Rey Juan Carlos	Madrid	Alcorcón

Sponsors (2)

Lead Sponsor	Collaborator
Nuria Máximo-Bocanegra	AlcaládeHenaresU

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical measures	These measures of the subject's physical condition shall be monitored while the subject is performing the assessment activities. This measure is heart rate measured in beats per minute.	Frist year
Primary	Physical measures 2	These measures of the subject's physical condition shall be monitored while the subject is performing the assessment activities. This measure is oxygen saturation expressed as a percentage.	Frist year
Primary	Accelerometry	Accelerometers will be used to measure energy expenditure expressed in METs.	Frist year
Primary	Accelerometry 2	Accelerometers will be used to measure walking speed in metres per second.	Frist year
Primary	Accelerometry 3	Accelerometers will be used to measure displacement or distance travelled in metres.	Frist year
Primary	Facial expression	Collected through the Observed Emotion Rating Scale (OERS), this is an observational measure with 6 types of emotions, 3 positive (pleasure, interest, satisfaction) and three negative (sadness, anxiety and anger). This scale is to be performed after a 10-minute observation. The scores are the observers' estimates of the amounts of time, during the 10-minute interval, that each emotion was exhibited: Never, < 16 sec, 15-59 sec, 1-5 min, > 5 min, and "can't say".	second year
Primary	Quality of performance	This is assessed using the standardised tool "Assessment of Motor Process Skills (AMPS)". It measures the quality of performance of tasks related to activities of daily living (ADL) in a natural environment. It is a tool designed to measure the interaction between the person, the ADL task and the environment.	second year
Primary	Functional ability	An assessment questionnaire known as the "Activities of Daily Living Questionnaire (ADLQ)" will be used. It measures a subject's functional ability and performance in 6 areas, which allow for a complete profile of deficits related to daily functioning. The final scores are calculated with a specific formula that provides a percentage of functional impairment from 0 to 100. There are total scores and scores per subscale.	second year
Primary	Severity of anxiety and depression	The Hamilton Anxiety Rating Score (HARS) is used to measure the severity of anxiety in a global way in subjects with anxiety or depression. In addition, this instrument is useful for monitoring response to treatment. It is a heteroadministered tool and the total score is the sum of each of the items, the range of scores being between 0 and 56.	second year
Primary	Self-perception of performance	The Canadian Occupational Performance Measure (COPM) is a semi-structured interview that allows for a dialogue between the patient and the assessor, designed to measure the patient's self-perception of performance in daily life. It assesses 3 areas: Self-care, Productivity (or work) and Leisure. Within each area, psychological, physical, socio-cultural and spiritual components are analysed, in addition to the performance and satisfaction linked to the performance of the activities. The total score will be an arithmetic mean for the performance value and another for satisfaction, the range can be from 1 to 10 and higher scores indicate better levels of performance and high satisfaction with performance.	second year
Primary	Functional cognitive performance	The Kettle Test is a performance test designed to indicate a person's ability to perform everyday tasks. The clinician observes while the subject completes the task, which involves making two hot drinks, one for the assessor and one for the subject. Performance is assessed and scores are based on 13 performance indices. Items are scored from 0 to 4. The score can be as high as 52, with higher scores revealing more severe performance problems.	second year
Primary	Cognitive processing	The Allen Cognitive Level Screen-5 (ACLS-5) is a measurement instrument established in the theoretical context of the cognitive impairment model, created by Claudia Allen.; It is used to obtain rapid information about global cognitive processing capacity, learning potential and performance abilities and to detect unknown or suspected problems related to functional cognition.	second year
Primary	Degree of disability and quality of life	To measure the degree of disability, the WHO Disability Assessment Scale, WHO-DAS 2.0 (WD2), measures changes in functioning and their levels of difficulty in performing and carrying out daily activities. The WD2 scale is composed of 36 items divided into 6 domains, assessed through a Likert scale with values from 1 to 5, referring to the difficulty presented. Higher scores indicate a greater degree of disability. The total score ranges from 36-180.	second year
Primary	Analytical validation	This step moves the evaluation procedure of EYEFUL sensors from the sensor itself (algorithm) to in vivo (evaluates on the person). In this phase, the data converts the sensor measurements into physiological metrics. The sensor measurements are compared with the Gold Standard scales mentioned above. Subsequently, an analysis of the convergent validity of the assessments will be made. Finally Eyeful, could be used to assess functional capabilities in a sample of subjects recruited with pathology to demonstrate that the developed systems acceptably identify, measure or predict functional status or experience in the defined context	Third year