- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07909824
Advanced Multisensorial System for Automatic Assessment of Neurological Disorders in Smart Spaces-Universidad Rey Juan Carlos (URJC) (NeurEYE-URJC)
Advanced Multisensorial System for Automatic Assessment of Neurological Disorders in Smart Spaces-URJC
Neurological diseases affect people's cognitive and physical abilities, limiting their functional independence and causing disability, which in many cases, is progressive and degenerative. Being able to perform activities of daily living is a challenge in these pathologies. Currently, different observational tools are administered to assess the degree of functional limitation in basic and instrumental Activities of Daily Living (ADL). However, the assessment must be performed in an ecological and real context to obtain objective information and ensure the most accurate assessment possible. To this end, it is necessary to consider the factors that influence the performance of ADLs and also on the quality of their execution, especially in this population in which the stressful situation of direct observation by an evaluator has a direct influence on the final score. Advanced Multisensorial System for Automatic Assessment of Neurological Disorders in Smart Spaces (NeurEYE) aims to develop technological tools to extract from sensory systems typical of intelligent spaces and with the help of signal processing and machine learning processes based on artificial intelligence, indicators of neurological impairment that influence functional capacity and function/dysfunction components while observing the performance of an activity of daily living. In addition, NeurEYE would provide as a scientific breakthrough the accurate description of subjects' limitations in the controlled assessment environment within the routine patient context. The NeurEye project will allow the clinical validation of a multisensory system that, through the detection of functional limitations in the ADLs of patients with neurological disorder, allows to establish the level of disability of the subjects. In addition, the qualitative and quantitative description of the functional alterations of the person with neurological disorders and, the elimination of the subjective bias of the examiner, will allow the generation of individualized clinical and statistical reports according to sex, activity, etc. that will be clinically useful in the early detection, diagnosis, and adaptation of rehabilitation treatments to the specific functional needs of neurological disorders.
연구 개요
상태
정황
상세 설명
The project has been funded by the Ministry of Science, Innovation and universities in the 2023 Call - "Knowledge Generation Projects" and actions for the training of predoctoral research staff associated with these projects. The Advanced Multisensorial System for Automatic Assessment of Neurological Disorders in Smart Spaces - Universidad Rey Juan Carlos (NeurEYE-URJC) project ref. PID2024-156576OB-C32 is part of a combined project with the University of Seville and the University of Alcalá de Henares. The NeurEYE-URJC project plays a leading role in the design of the methodology, and clinical validation, with the collaboration of the NeurEYE-Universidad de Alcalá (NeurEYE-UAH) and NeurEYE-Universidad de Sevilla (NeurEYE-US) projects being necessary to provide detailed feedback on the current and foreseeable possibilities of cutting-edge technology for the analysis of human behaviour. This proposal is linked to the "Health" priority of the State Plan for Scientific Research. In addition, the project is also directed towards the second pillar of the Global Challenges within those of Horizon Europe. More specifically, towards some of the main objectives of the Health Cluster.
Neurological diseases are one of the main causes of disability. In Spain, this type of pathology is responsible for 44% of disability due to chronic diseases and 50% of the years lost due to disability. ADLs are fundamental skills for maintaining and caring for oneself, therefore, the inability to perform them properly results in a state of dependency, which implies the need for some kind of help or assistance and, therefore, entails high financial and care costs.
However, there are important limitations in their application: first, no "gold standard" has been determined for the evaluation of functionality, second, the information they detail is not related to the quality of execution, third, they have practical limitations such as long administration times, fourth, the subjectivity of the evaluator and the biases it produces; gender and culture, interviewee biases for feeling observed by another person and in the case of interviews, recall biases that can occur in self-administered tools, because they are based on the recall of performance in the ADL and we can find that those who are evaluated consider their problem as unimportant, are aware of their problem but deny it or do not report it accurately and/or realistically. In addition, we may encounter evaluator bias, since observational assessment instruments require professional training to administer them.
The use of technology is an innovative strategy that can bring great improvements in the evaluation of functional performance, as it can objectively measure performance in an activity and the required behaviors through para-based monitoring.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marta Pérez de Heredia Torres, PhD
- 전화번호: +34914888886
- 이메일: marta.perezdeheredia@urjc.es
연구 연락처 백업
- 이름: Rosa M Martínez Piédrola, PhD
- 전화번호: +34914888887
- 이메일: rosa.martinez@urjc.es
연구 장소
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Madrid
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Alcorcón, Madrid, 스페인, 28922
- Facultad de Ciencias de la Salud. Universidad Rey Juan Carlos
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연락하다:
- Marta Pérez de Heredia Torres, PhD
- 전화번호: +34914888886
- 이메일: marta.perezdeheredia@urjc.es
-
연락하다:
- Rosa M Martínez Piédrola, PhD
- 전화번호: +3491488887
- 이메일: rosa.martinez@urjc.es
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The Control group sample (subjects without pathology over the age of 18) will be obtained using non-probability convenience sampling. Recruitment will be carried out from the researchers' immediate circle. The experimental group sample (adults diagnosed with a neurological disease) is proposed through a non-probabilistic sampling of consecutive cases from collaborating hospitals and patient associations [Spanish Federation of Parkinson's Disease Associations, the Synaptia Vithas Neuroscience Institute, the University Hospital of Guadalajara and the National Paraplegic Hospital of Toledo].
설명
Inclusion Criteria:
- Time since diagnosis.
- Mini-Mental State Examination (Folstein) score between 10 and 30 (no impairment or moderate cognitive impairment).
- Barthel Index score between 100 and 61 (independent or mildly dependent).
- On stable medical treatment for three months prior to assessment.
Exclusion Criteria:
- Diagnosis of a musculoskeletal disorder or diagnosis of any cardiovascular, respiratory, or metabolic disease, or other conditions that may interfere.
- Failure to sign the informed consent form.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Healthy people
Undiagnosed persons will be evaluated by the NeurEYE system performing activities of daily living. Patterns of action will be recorded to establish outcome measures in healthy population. |
The data to be captured are exclusively video and audio recordings, and different signals from smartwatches (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 neurological diseases
People with neurological diseases will be evaluated by the NeurEYE system performing activities of daily living. Patterns of action will be recorded, to establish outcome measures in healthy population. |
The data to be captured are exclusively video andaudio recordings, and different signals from smartwatches (mainly related to movement). Addittionaly, the clinical evaluation of the performance of these activities will be carried out according to theassessment 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cognitive assessment
기간: First year
|
Rivermead Behavioural Memory Test (RBMT) is a standardized memory assessment tool designed to evaluate how memory problems affect a person's daily functioning. It primarily assesses prospective memory, verbal memory, visual memory, recognition, and orientation through tasks that simulate everyday situations. It is a widely used test in clinical and research settings, with adequate psychometric properties (reliability and validity) and sensitivity for detecting memory impairments associated with brain damage, neurodegenerative diseases, and other neurological conditions. It is administered individually by a trained professional. It includes various functional tasks, such as recalling names, routes, messages, or personal belongings. |
First year
|
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Grip strength assessment
기간: First year
|
To measure grip strength the Jamar dynamometer is a standardized instrument used to measure handgrip strength, a relevant indicator of upper limb muscle function and overall functional status. It is frequently used in rehabilitation, neurology, geriatrics, and musculoskeletal assessment. It is considered the gold standard for grip strength assessment. It exhibits high reliability, validity, and reproducibility, making it widely used in both clinical practice and research. |
First year
|
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Manual dexterity
기간: First year
|
The Nine Hole Peg Test (NHPT) is a standardized test used to assess fine motor dexterity and upper limb motor coordination. It measures how quickly a person can place and remove nine pegs from a pegboard and is widely used in neurology and rehabilitation. It is a well-validated tool with good reliability, validity, and sensitivity for detecting changes in manual function. It is frequently used in research and clinical practice with populations affected by stroke, multiple sclerosis, Parkinson's disease, and other neurological conditions. |
First year
|
|
Cognitive abilities
기간: First year
|
The Trail Making Test (TMT) is a standardized neuropsychological test that assesses processing speed, visual attention, cognitive flexibility, and executive functions. It can be administered by occupational therapists. It consists of two parts: Part A involves connecting numbers in sequence, and Part B involves alternating numbers and letters in a predetermined order. It is one of the most widely used and validated tests in neuropsychology. It exhibits adequate psychometric properties, good reliability, and sensitivity for detecting cognitive impairments associated with brain damage, aging, dementia, and other neurological diseases. |
First year
|
|
Language
기간: First year
|
The Quick Aphasia Battery (QAB) is an standardized tool designed to quickly assess the presence and severity of language impairments in individuals with aphasia. It evaluates various language domains, including auditory comprehension, verbal expression, repetition, naming, reading, and language fluency. It is a validated test with good psychometric properties, allowing for the reliable identification and quantification of language deficits. It has proven useful in both clinical and research settings, particularly in patients with stroke and other acquired neurological injuries. |
First year
|
|
Behavioral
기간: First Year
|
Lille Apathy Rating Scale (LARS) is a standardized tool designed to assess apathy in individuals with neurological disorders. It analyzes different dimensions of this syndrome, including motivation, interest, initiative, participation in activities, and emotional response. It is a widely used and validated scale, especially in Parkinson's disease and other neurological conditions. It exhibits good internal consistency, high inter-rater reliability, and adequate construct and criterion validity, allowing for the reliable identification and quantification of apathy severity. |
First Year
|
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Depression
기간: First year
|
Mini-DASS (Mini Depression Anxiety Stress Scales). Designed to assess emotional distress across three main dimensions: depression, anxiety, and stress. It is used as a screening tool to identify emotional symptoms and monitor changes over time. It is a measure based on the theoretical model of the Depression Anxiety Stress Scales, which has been widely validated in general and clinical populations. The abbreviated versions have shown adequate validity and reliability, maintaining a good ability to discriminate between depressive, anxious, and stress symptoms. Good internal consistency for the total score and its subscales, with Cronbach's alpha coefficients generally above 0.70. Adequate convergent validity with other measures of depression, anxiety, and emotional well-being. Good sensitivity for detecting mild, moderate, and high levels of psychological distress. A factor structure consistent with the dimensions of depression, anxiety |
First year
|
|
Apraxia
기간: First Year
|
Test of Upper Limb Apraxia (TULIA). This is a standardized tool designed to assess upper limb apraxia, that is, difficulties in planning and executing learned movements voluntarily despite preserving basic strength, sensation, and comprehension. It evaluates the imitation and execution of both transitive (object use) and intransitive (communicative) movements. It is a widely validated test for the assessment of apraxia following stroke and other neurological injuries. It exhibits high reliability, validity, and discriminative power, making it one of the reference tools for the clinical and research assessment of upper limb apraxia. |
First Year
|
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Attentional deficit
기간: First Year
|
Star Cancellation Test is a screening test used to assess unilateral spatial hemineglect, a common impairment following brain injury, especially after a right hemisphere stroke. It evaluates a person's ability to visually explore space and identify stimuli distributed on a sheet of paper. It is one of the most widely used tests for detecting spatial hemineglect. It has demonstrated good clinical validity and sensitivity for identifying visuospatial attention deficits, and is included in widely used batteries in neurology and neurorehabilitation, such as the Behavioral Inattention Test (BIT). |
First Year
|
|
Sensibility 1
기간: First year
|
Algometry (pressure pain threshold measurement) is a standardized technique used to assess sensitivity to mechanical pain by measuring the pressure pain threshold (PPT). It allows for the objective quantification of the minimum pressure that elicits a painful sensation and is frequently used in patients with musculoskeletal disorders, chronic pain, and neurological conditions. Algometry is a widely used method in research and clinical practice for pain assessment. It exhibits good validity and reliability when performed with standardized protocols, and is particularly useful for monitoring changes in pain sensitivity and response to treatments. |
First year
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Sensibility 2
기간: Second year
|
The Visual Analogue Scale (VAS) is a self-report tool used to evaluate the intensity of perceived pain. It typically consists of a 10 cm line whose ends represent "no pain" and "worst imaginable pain," allowing for a simple quantification of the subjective experience of pain. It is one of the most widely used pain measures in clinical practice and research. It exhibits adequate validity, reliability, and sensitivity to change, and is considered a gold standard for assessing pain intensity and monitoring the response to therapeutic interventions. |
Second year
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Motor function
기간: First year
|
Box and Block Test (BBT) This is a standardized test used to assess gross manual dexterity and unilateral upper extremity motor function. It measures a person's ability to grasp, carry, and release wooden blocks from one compartment to another within a specified time. It is one of the most widely used tools for assessing manual function in rehabilitation, neurology, and occupational therapy. It exhibits strong psychometric properties and is sensitive in detecting motor deficits and functional changes following therapeutic intervention. |
First year
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Functional gait
기간: First Year
|
Functional Gait Assessment (FGA) is an observational scale designed to assess functional gait and dynamic balance during various tasks that challenge postural control. It analyzes an individual's ability to walk under different conditions, such as changes in speed, head turns, walking with obstacles, quick turns, and stair climbing. It is a widely used tool in neurology, geriatrics, and rehabilitation. Derived from the Dynamic Gait Index (DGI), it exhibits good psychometric properties and a high capacity for identifying dynamic balance impairments and fall risk in individuals with neurological and vestibular disorders. |
First Year
|
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Postural control
기간: First year
|
Sensory Organization Test (SOT). This instrumental test assesses postural control and balance by analyzing how a person uses and integrates visual, vestibular, and somatosensory information to maintain stability. It is one of the most widely used tests within computerized dynamic posturography. The SOT is considered a gold standard for the objective assessment of balance. It has high validity and reliability and is widely used in research and clinical practice to evaluate balance impairments associated with neurological, vestibular, and musculoskeletal disorders. |
First year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- A726
- 2025 (미국 NIH 보조금/계약)
- 2025/00420/006 (기타 보조금/기금 번호: AGENCIA ESTATAL INVESTIGACION)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
No personal data of participants will be shared
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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