Handicaps PhysicalEYEFULNCT05385328
Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations
An observational study of Handicaps Physical and Fetal Alcohol Syndrome, run by Nuria Máximo-Bocanegra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Handicaps Physical, Fetal Alcohol Syndrome, Mental Disability
- What is being tested?
- EYEFUL: healthy people and EYEFUL: people with pathology
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Facultad Ciencias de la Salud. Universidad Rey Juan Carlos
Madrid, Alcorcón, 28922
Marta Mrs Pérez de Heredia Torres, PhD, 34914888886, marta.perezdeheredia@urjc.es
About this study
Official title: Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations (EYEFUL)
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.
Read the 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.
- Being tested
- EYEFUL: healthy people, EYEFUL: people with pathology
- Keywords
- Activities of Daily Life, Clinical evaluation, Multisensorial analysis
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEFUL: healthy peopleDevice
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 pathologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EYEFUL: people with pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Frist year
Accelerometry
Accelerometers will be used to measure energy expenditure expressed in METs.
Measured: Frist year
Accelerometry 2
Accelerometers will be used to measure walking speed in metres per second.
Measured: Frist year
Accelerometry 3
Accelerometers will be used to measure displacement or distance travelled in metres.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Third year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Nov 2022
- Primary completion31 Mar 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handicaps PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuria Máximo-Bocanegra
- Sponsor type
- University, hospital or other
- Collaborators
- AlcaládeHenaresU
- Responsible party
- Sponsor-investigator, Nuria Máximo-Bocanegra, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385328
- Sponsor's protocol ID
- KingJuanCarlosU
- Acronym
- EYEFUL
- Status last verified
- Nov 2022
- First submitted
- 21 Feb 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal data of participants will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations (EYEFUL)
- ClinicalTrials.gov ID
- NCT05385328
- Acronym / sponsor ID
- EYEFUL / KingJuanCarlosU
- Keywords
- Activities of Daily Life, Clinical evaluation, Multisensorial analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nuria Máximo-BocanegraUniversity, hospital or other
- Collaborators
- AlcaládeHenaresU
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | Device: EYEFUL: healthy peopleUndiagnosed 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. |
| people with physical or psychological diagnoses | – | Device: EYEFUL: people with pathologyPeople 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYEFUL: healthy peopleThis 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. | Device | Healthy people |
| EYEFUL: people with pathologyThis 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. | Device | people with physical or psychological diagnoses |
Primary outcome
Physical measures
Time frame: Frist year
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.
Physical measures 2
Time frame: Frist year
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.
Accelerometry
Time frame: Frist year
Accelerometers will be used to measure energy expenditure expressed in METs.
Accelerometry 2
Time frame: Frist year
Accelerometers will be used to measure walking speed in metres per second.
Accelerometry 3
Time frame: Frist year
Accelerometers will be used to measure displacement or distance travelled in metres.
Facial expression
Time frame: second year
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".
Quality of performance
Time frame: second year
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.
Functional ability
Time frame: second year
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.
Severity of anxiety and depression
Time frame: second year
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.
Self-perception of performance
Time frame: second year
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.
Functional cognitive performance
Time frame: second year
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.
Cognitive processing
Time frame: second year
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.
Degree of disability and quality of life
Time frame: second year
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.
Analytical validation
Time frame: Third year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. No personal data of participants will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Handicaps Physical and Fetal Alcohol Syndrome, run by Nuria Máximo-Bocanegra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Pérez-de-Heredia-Torres (34914888886, marta.perezdeheredia@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical measures (time frame: Frist year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.