Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations (EYEFUL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Physical measures 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physical measures 2
时间窗: 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 2
时间窗: Frist year
Accelerometers will be used to measure walking speed in metres per second.
Functional cognitive performance
时间窗: 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.
Accelerometry 3
时间窗: Frist year
Accelerometers will be used to measure displacement or distance travelled in metres.
Facial expression
时间窗: 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
时间窗: 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
时间窗: 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.
Self-perception of performance
时间窗: 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.
Cognitive processing
时间窗: 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.
Analytical validation
时间窗: 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
Severity of anxiety and depression
时间窗: 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.
Physical measures
时间窗: 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.
Accelerometry
时间窗: Frist year
Accelerometers will be used to measure energy expenditure expressed in METs.
Degree of disability and quality of life
时间窗: 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.
次要结局
未报告次要终点
研究者
Nuria Máximo-Bocanegra
Occupational Therapist Philosophy Doctor (PhD) (team investigator)
Universidad Rey Juan Carlos