Clinical trial NCT04456348: Association Between Gait Assessed by Intelligent System and Cognitive Function in Silent Cerebrovascular Disease
Official title: Association Between Gait Features Assessed by Artificial Intelligent System and Cognitive Function Decline in the Patients of Silent Cerebrovascular Disease: A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Silent Stroke
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Guizhou Medical University
name: Fudan University
First posted: 2020-07-02
Enrollment: 1600
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: with silent cerebrovascular disease patient aged 60 to 85 in Shanghai and Guizhou

Brief summary: This study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory examinations, imaging examinations, and other clinical data and health economics survey responses will be collected from all subjects.

At baseline, all subjects will undergo gait assessment using the intelligent system and cognitive function scale assessment by clinicians. According to the intelligent gait results, the subjects will be divided into normal and abnormal gait groups. All subjects will be observed naturally for 1 year, and all medical behaviors will be recorded. All subjects will be interviewed by telephone for the occurrence of vascular events and changes in medical behaviors at half a year after enrollment and followed up at 1 year after enrollment, including gait evaluation using the intelligent system and cognitive function scale evaluation by clinicians. During the follow-up period, patients can visit the hospital for follow-up at any time when their condition changes.

Detailed description: The neurological function of all subjects was assessed based on the following tests under the guidance of a physician. The timed up-and-go test was used to evaluate the subjects' gait function, requiring them to stand up from their seat and walk straight forward for 3 meters, turn around, walk straight back to the chair, and then sit down again. Using simple cognitive evaluation (Mini-Cognitive Assessment) screening of the subjects' memory and executive function, the participants will first be asked to remember three unrelated words and immediately repeat the three words; they will then be asked to draw a clock marked with the numbers and pointers, and eventually recall the three words. The verbal function of the subjects will be assessed using the verbal retelling items in the MMSE and Montreal Cognitive Assessment, asking the subjects to clearly repeat "44 stone lions," "I only know Zhang Liang came to help today," and "the cat always hid under the sofa when the dog was in the room." Through the camera image data record, the intelligent system uses the built-in intelligent algorithm for intelligent video gait recognition and neural networks based on depth interpretation automation and automatic access to the subjects' gait characteristics (stand-up time, turnaround time, stride length, step velocity, stride length, step width, etc.), language features (pronunciation, intonation, word order, language accuracy, language fluency, etc.), and clock features.

Eligibility criteria: Inclusion Criteria:

1. Aged between 60 and 85 years.
2. Diagnosed with silent cerebrovascular disease/silent stroke, which is consistent with the 2016 statement issued by the American Heart Association (AHA) and American Stroke Association (ASA):

   1. No previous clear history of stroke and no clinical symptoms or mild clinical symptoms that fail to attract clinical attention;
   2. Cranial MRI showing at least one of the following within 5 years: lacunar infarct of vascular origin; white matter hyperintensity of vascular origin; cerebral microbleeds;
3. Consciousness and ability to complete cognitive assessment
4. Ability to stand and walk independently and complete gait assessment without assistance from others.
5. Ability to sign the informed consent.

Exclusion Criteria:

1. Intracranial lesions that have been clearly diagnosed as demyelination disease, white matter dystrophy, intracranial space-occupying lesions, or autoimmune encephalitis.
2. Gait disorder that has been diagnosed as Parkinson's disease, normal cranial hydrocephalus, an otogenic disease, subacute combined degeneration, peripheral neuropathy, osteoarthritis, or lumbar disease.
3. Cognitive disorders that have been diagnosed, such as Alzheimer's disease, frontotemporal dementia, Lewy body dementia, etc.
4. Severe neurological diseases such as previous cerebral trauma, epilepsy, and myelopathy, etc.
5. Severe cardiovascular complications and intolerance to the assessment
6. Severe visual or hearing impairment, aphasia, cognitive disorder, gait disorder, etc., that results in the inability to cooperate for cognitive and gait assessment
7. Refusal to participate in the study
8. Other anomalies that could not be included in the exclusion criteria, but are considered inappropriate to be included in this study.

Primary outcomes:
measure: Change in cognitive assessment scale score(MMSE)
timeFrame: 1 year
Secondary outcomes:
measure: Change in cognitive assessment scale score(MoCA)
timeFrame: 1 year
measure: the prevalence of gait disorders
timeFrame: baseline
measure: the prevalence of cognitive disorder
timeFrame: baseline
measure: the incidence of vascular events
timeFrame: 1 year
measure: the incidence of fall incidence
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jing Ding, MD
role: STUDY_DIRECTOR
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