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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
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Silent Stroke

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    July 1, 2020
    Last Updated
    July 1, 2020
    Sponsor
    Shanghai Zhongshan Hospital
    Collaborators
    Fudan University, The Affiliated Hospital Of Guizhou Medical University
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    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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