the Effectiveness and Cost Effectiveness in Screening Gait Disorder of Silent Cerebrovascular Disease Assisted by Artificial Intelligent System and Clinical Doctors - A Randomized Parallel-controlled Study
Trial ID: NCT04457908
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2020-07-01
Completion date: 2020-12-31
Sponsor: Shanghai Zhongshan Hospital
Collaborators: Fudan University; The Affiliated Hospital Of Guizhou Medical University
Conditions: Silent Stroke
Interventions: intelligent assessment
Enrollment: 1000
Age range: 60 Years - 85 Years
Sex: ALL

Summary:
This is a multi-center, randomized, double-blind, parallel-controlled, prospective study to compare the effectiveness and cost-effectiveness of intelligent and doctor groups for gait disorder screening.

Clinical data, including demographic characteristics, socioeconomic level, medical history, assessment of neurological function, laboratory tests, imaging tests, health service utilization, and costs will be collected from the subjects. All subjects will be divided into an intelligent group and a doctor group according to a 1:1 ratio. The intelligent group will undergo intelligent system evaluation, and the doctor group will undergo the clinician's conventional treatment process. At the same time, all the subjects will undergo gold-standard panel gait and cognitive rating scale assessments.

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.

Outcomes:
Sensitivity