Association Between Gait Assessed by Intelligent System and Cognitive Function in Silent Cerebrovascular Disease (ACCURATE-2)

June 30, 2020 updated by: Shanghai Zhongshan Hospital

Association Between Gait Features Assessed by Artificial Intelligent System and Cognitive Function Decline in the Patients of Silent Cerebrovascular Disease: A Multicenter Prospective Cohort Study

This study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory examinations, imaging examinations, and other clinical data and health economics survey responses will be collected from all subjects.

At baseline, all subjects will undergo gait assessment using the intelligent system and cognitive function scale assessment by clinicians. According to the intelligent gait results, the subjects will be divided into normal and abnormal gait groups. All subjects will be observed naturally for 1 year, and all medical behaviors will be recorded. All subjects will be interviewed by telephone for the occurrence of vascular events and changes in medical behaviors at half a year after enrollment and followed up at 1 year after enrollment, including gait evaluation using the intelligent system and cognitive function scale evaluation by clinicians. During the follow-up period, patients can visit the hospital for follow-up at any time when their condition changes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The neurological function of all subjects was assessed based on the following tests under the guidance of a physician. The timed up-and-go test was used to evaluate the subjects' gait function, requiring them to stand up from their seat and walk straight forward for 3 meters, turn around, walk straight back to the chair, and then sit down again. Using simple cognitive evaluation (Mini-Cognitive Assessment) screening of the subjects' memory and executive function, the participants will first be asked to remember three unrelated words and immediately repeat the three words; they will then be asked to draw a clock marked with the numbers and pointers, and eventually recall the three words. The verbal function of the subjects will be assessed using the verbal retelling items in the MMSE and Montreal Cognitive Assessment, asking the subjects to clearly repeat "44 stone lions," "I only know Zhang Liang came to help today," and "the cat always hid under the sofa when the dog was in the room." Through the camera image data record, the intelligent system uses the built-in intelligent algorithm for intelligent video gait recognition and neural networks based on depth interpretation automation and automatic access to the subjects' gait characteristics (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.

Study Type

Observational

Enrollment (Anticipated)

1600

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

Sampling Method

Probability Sample

Study Population

with silent cerebrovascular disease patient aged 60 to 85 in Shanghai and Guizhou

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
positive
Subjects have gait disorder according to intelligent gait assessment at baseline.
Other: there is no intervention
There is no intervention
negative
Subjects don't have gait disorder according to intelligent gait assessment at baseline.
Other: there is no intervention
There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive assessment scale score(MMSE)
Time Frame: 1 year
It will be assessed by the Mini-Mental state examination (MMSE), which is scored 0-30.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive assessment scale score(MoCA)
Time Frame: 1 year
It will be assessed by the Montreal cognitive assessment (MoCA), which is scored 0-30.
1 year
the prevalence of gait disorders
Time Frame: baseline
the prevalence of gait disorders, according to the intelligent assessment
baseline
the prevalence of cognitive disorder
Time Frame: baseline
the prevalence of cognitive disorder, according to the MMSE
baseline
the incidence of vascular events
Time Frame: 1 year
the incidence of vascular events, including Cardiovascular and cerebrovascular events
1 year
the incidence of fall incidence
Time Frame: 1 year
the incidence of fall incidence
1 year

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, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018YFC1312900-01

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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