The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease (ACCURATE-1)

July 1, 2020 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intelligent
receive the neurological function assessment by artificial intelligence
Diagnostic test: intelligent assessment
intelligent neurological function assessment
No Intervention: manual
receive the neurological function assessment by doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: baseline
Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: baseline
the specificity of the intelligent system and clinicians to screen for gait disorders
baseline
Coincidence
Time Frame: baseline
the coincidence of the intelligent system and clinicians to screen for gait disorders
baseline
Yoden index
Time Frame: baseline
the Yoden index of the intelligent system and clinicians to screen for gait disorders
baseline
Positive predictive value and negative predictive value
Time Frame: baseline
the positive predictive value and negative predictive value of the intelligent system and clinicians at different levels to screen for gait disorders
baseline
Cost and cost-effectiveness
Time Frame: baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Fudan University
The Affiliated Hospital Of Guizhou Medical University

Investigators

  • Study Director: Jing Ding, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018YFC1312900-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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