Status:
UNKNOWN
The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Fudan University
The Affiliated Hospital Of Guizhou Medical University
Conditions:
Silent Stroke
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 screenin...
Detailed Description
All subjects in the intelligent group will undergo tests to evaluate their nervous system function, including the timed up-and-go test, mini-cognitive assessment, and sentence repetition. Subjects wil...
Eligibility Criteria
Inclusion
- Aged between 60 and 85 years.
- 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):
- No previous clear history of stroke and no clinical symptoms or mild clinical symptoms that fail to attract clinical attention;
- 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;
- Consciousness and ability to complete cognitive assessment
- Ability to stand and walk independently and complete gait assessment without assistance from others.
- Ability to sign the informed consent.
Exclusion
- Intracranial lesions that have been clearly diagnosed as demyelination disease, white matter dystrophy, intracranial space-occupying lesions, or autoimmune encephalitis.
- 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.
- Cognitive disorders that have been diagnosed, such as Alzheimer's disease, frontotemporal dementia, Lewy body dementia, etc.
- Severe neurological diseases such as previous cerebral trauma, epilepsy, and myelopathy, etc.
- Severe cardiovascular complications and intolerance to the assessment
- Severe visual or hearing impairment, aphasia, cognitive disorder, gait disorder, etc., that results in the inability to cooperate for cognitive and gait assessment
- Refusal to participate in the study
- Other anomalies that could not be included in the exclusion criteria, but are considered inappropriate to be included in this study.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04457908
Start Date
July 1 2020
End Date
December 31 2020
Last Update
July 7 2020
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