Fetal Alcohol Syndrome Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Active, not recruiting |
NCT00996528 -
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
|
Phase 3 | |
Completed |
NCT00164229 -
Fetal Alcohol Syndrome: Socio-Cognitive Habilitation
|
Phase 1/Phase 2 | |
Completed |
NCT00164554 -
Fetal Alcohol Syndrome/ARND Research Consortion
|
Phase 1/Phase 2 | |
Recruiting |
NCT05534568 -
The Oklahoma Parent-Child Assistance Program
|
N/A | |
Completed |
NCT01911299 -
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
|
Phase 2 | |
Terminated |
NCT00747630 -
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
|
Phase 0 | |
Recruiting |
NCT04332172 -
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
|
N/A | |
Completed |
NCT00696085 -
Fetal Alcohol Damage Prevention Study
|
N/A | |
Recruiting |
NCT00418262 -
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
|
Phase 3 | |
Completed |
NCT01149538 -
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
|
Phase 1/Phase 2 | |
Recruiting |
NCT03371641 -
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
|
N/A | |
Completed |
NCT00164346 -
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
|
Phase 1/Phase 2 | |
Completed |
NCT01994603 -
Expansion to Interdisciplinary HIV Prevention in Women
|
N/A | |
Completed |
NCT00417794 -
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
|
Phase 1 | |
Completed |
NCT02600624 -
Prenatal Alcohol Biomarker Study in Uruguay
|
||
Completed |
NCT00244062 -
Healthy Moms Alcohol Intervention
|
N/A | |
Recruiting |
NCT04395196 -
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
|
Phase 2 |