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

NCT05385328 | Unknown DMC

• 1 other identifier: KingJuanCarlosU
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Handicaps Physical; Fetal Alcohol Syndrome; Mental Disability

Keywords

Activities of Daily Life; Clinical evaluation; Multisensorial analysis

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• Accelerometry

  Accelerometers will be used to measure energy expenditure expressed in METs.

  Frist year

• Accelerometry 2

  Accelerometers will be used to measure walking speed in metres per second.

  Frist year

• Accelerometry 3

  Accelerometers will be used to measure displacement or distance travelled in metres.

  Frist year

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Healthy people

Undiagnosed persons will be evaluated by the EYEFUL system performing activities of daily living. Patterns of action will be recorded, to establish outcome measures in healthy population.

Device: EYEFUL: healthy people

people with physical or psychological diagnoses

People with various clinical diagnoses will be evaluated by the EYEFUL system performing activities of daily living. Patterns of action will be recorded, in order to establish outcome measures in comparison with healthy population and with other diagnoses.

Device: EYEFUL: people with pathology

Interventions

EYEFUL: healthy people DEVICE

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.

Healthy people

EYEFUL: people with pathology DEVICE

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.

people with physical or psychological diagnoses

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuria Máximo-Bocanegra: lead
• AlcaládeHenaresU: collaborator

Study Sites (1)

Facultad Ciencias de la Salud. Universidad Rey Juan Carlos

Madrid, Alcorcón, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Marta Pérez-de-Heredia-Torres

CONTACT

34914888886; marta.perezdeheredia@urjc.es

Nuria Máximo-Bocanegra

CONTACT

34914888856; nuria.maximo@urjc.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Occupational Therapist Philosophy Doctor (PhD) (team investigator)

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: May 23, 2022
• Study Start: November 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: August 31, 2024
• Last Updated: November 29, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)