The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease (ACCURATE-1)
Primary Purpose
Silent Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intelligent assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Silent Stroke
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
intelligent
manual
Arm Description
receive the neurological function assessment by artificial intelligence
receive the neurological function assessment by doctor
Outcomes
Primary Outcome Measures
Sensitivity
Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders
Secondary Outcome Measures
Specificity
the specificity of the intelligent system and clinicians to screen for gait disorders
Coincidence
the coincidence of the intelligent system and clinicians to screen for gait disorders
Yoden index
the Yoden index of the intelligent system and clinicians to screen for gait disorders
Positive predictive value and negative predictive value
the positive predictive value and negative predictive value of the intelligent system and clinicians at different levels to screen for gait disorders
Cost and cost-effectiveness
Health care utilization and costs will be collected to calculate direct and indirect costs of the intelligent system and clinicians to screen for gait disorders, and the incremental cost-effectiveness ratio (ICER) will be computed.
Full Information
NCT ID
NCT04457908
First Posted
July 1, 2020
Last Updated
July 1, 2020
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Fudan University, The Affiliated Hospital Of Guizhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04457908
Brief Title
The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease
Acronym
ACCURATE-1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Fudan University, The Affiliated Hospital Of Guizhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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 will be recorded using a camera and microphone. The intelligent system uses the built-in intelligent algorithm to analyze the gait video, sound, and picture to provide information on gait features (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 (contour, numbers, pointers, etc.).
All subjects in the doctor group will consult with a doctor in the non-intelligent group according to the routine treatment procedure. Doctors in the non-intelligent group are required to be internal medicine clinicians with intermediate title or below, and they should have registered their qualifications, relevant knowledge and training experience, educational background, and other information in the early stage of the study. The doctors in the non-intelligent group will make clinical diagnoses for the subjects based on routine medical operations such as a history of the present illness, previous history, and physical examination, and the data in medical records in the outpatient department will help determine whether the subjects have gait disorders.
All subjects' walking videos will be assessed by the gold-standard panel, which will consist of 2 experts of movement disorders. If there is any difference, a third expert will be included in the evaluation. According to the clinical experience, the expert doctors will evaluate the subjects' gait, and the results will be divided into normal gait and abnormal gait.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Silent Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intelligent
Arm Type
Other
Arm Description
receive the neurological function assessment by artificial intelligence
Arm Title
manual
Arm Type
No Intervention
Arm Description
receive the neurological function assessment by doctor
Intervention Type
Diagnostic Test
Intervention Name(s)
intelligent assessment
Intervention Description
intelligent neurological function assessment
Primary Outcome Measure Information:
Title
Sensitivity
Description
Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Specificity
Description
the specificity of the intelligent system and clinicians to screen for gait disorders
Time Frame
baseline
Title
Coincidence
Description
the coincidence of the intelligent system and clinicians to screen for gait disorders
Time Frame
baseline
Title
Yoden index
Description
the Yoden index of the intelligent system and clinicians to screen for gait disorders
Time Frame
baseline
Title
Positive predictive value and negative predictive value
Description
the positive predictive value and negative predictive value of the intelligent system and clinicians at different levels to screen for gait disorders
Time Frame
baseline
Title
Cost and cost-effectiveness
Description
Health care utilization and costs will be collected to calculate direct and indirect costs of the intelligent system and clinicians to screen for gait disorders, and the incremental cost-effectiveness ratio (ICER) will be computed.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beini Fei, MB
Phone
+86 13701699684
Email
fbeini@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ding, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease
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