The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease

NCT04457908 | Unknown

• 1 other identifier: 2018YFC1312900-05
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Silent Stroke

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders

  baseline

Secondary Outcomes (5)

• Specificity

  baseline

• Coincidence

  baseline

• Yoden index

  baseline

• Positive predictive value and negative predictive value

  baseline

• Cost and cost-effectiveness

  baseline

Study Arms (2)

intelligent

OTHER

receive the neurological function assessment by artificial intelligence

Diagnostic Test: intelligent assessment

manual

NO INTERVENTION

receive the neurological function assessment by doctor

Interventions

intelligent assessment DIAGNOSTIC_TEST

intelligent neurological function assessment

intelligent

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Fudan University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator

Related Publications (19)

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  PMID: 35332042 DERIVED

Study Officials

• Jing Ding, MD

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Beini Fei, MB

CONTACT

+86 13701699684; fbeini@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 7, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share