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

Silent Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04457908
• Other study ID #: 2018YFC1312900-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Beini Fei, MB
• Phone: +86 13701699684
• Email: fbeini[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Silent Stroke

Intervention

Diagnostic Test:
• intelligent assessment
intelligent neurological function assessment

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Fudan University, The Affiliated Hospital Of Guizhou Medical University

References & Publications (18)

Brickman AM, Provenzano FA, Muraskin J, Manly JJ, Blum S, Apa Z, Stern Y, Brown TR, Luchsinger JA, Mayeux R. Regional white matter hyperintensity volume, not hippocampal atrophy, predicts incident Alzheimer disease in the community. Arch Neurol. 2012 Dec;69(12):1621-7. doi: 10.1001/archneurol.2012.1527. — View Citation

de Laat KF, van Norden AG, Gons RA, van Oudheusden LJ, van Uden IW, Bloem BR, Zwiers MP, de Leeuw FE. Gait in elderly with cerebral small vessel disease. Stroke. 2010 Aug;41(8):1652-8. doi: 10.1161/STROKEAHA.110.583229. Epub 2010 Jun 24. — View Citation

Debette S, Markus HS. The clinical importance of white matter hyperintensities on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ. 2010 Jul 26;341:c3666. doi: 10.1136/bmj.c3666. Review. — View Citation

Dumurgier J, Artaud F, Touraine C, Rouaud O, Tavernier B, Dufouil C, Singh-Manoux A, Tzourio C, Elbaz A. Gait Speed and Decline in Gait Speed as Predictors of Incident Dementia. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):655-661. doi: 10.1093/gerona/ — View Citation

Kim BJ, Lee SH. Prognostic Impact of Cerebral Small Vessel Disease on Stroke Outcome. J Stroke. 2015 May;17(2):101-10. doi: 10.5853/jos.2015.17.2.101. Epub 2015 May 29. Review. — View Citation

Kim YJ, Kwon HK, Lee JM, Cho H, Kim HJ, Park HK, Jung NY, San Lee J, Lee J, Jang YK, Kim ST, Lee KH, Choe YS, Kim YJ, Na DL, Seo SW. Gray and white matter changes linking cerebral small vessel disease to gait disturbances. Neurology. 2016 Mar 29;86(13):1199-207. doi: 10.1212/WNL.0000000000002516. Epub 2016 Mar 2. — View Citation

Leary MC, Saver JL. Annual incidence of first silent stroke in the United States: a preliminary estimate. Cerebrovasc Dis. 2003;16(3):280-5. — View Citation

Maillard P, Carmichael O, Fletcher E, Reed B, Mungas D, DeCarli C. Coevolution of white matter hyperintensities and cognition in the elderly. Neurology. 2012 Jul 31;79(5):442-8. doi: 10.1212/WNL.0b013e3182617136. Epub 2012 Jul 18. — View Citation

Montero-Odasso MM, Sarquis-Adamson Y, Speechley M, Borrie MJ, Hachinski VC, Wells J, Riccio PM, Schapira M, Sejdic E, Camicioli RM, Bartha R, McIlroy WE, Muir-Hunter S. Association of Dual-Task Gait With Incident Dementia in Mild Cognitive Impairment: Results From the Gait and Brain Study. JAMA Neurol. 2017 Jul 1;74(7):857-865. doi: 10.1001/jamaneurol.2017.0643. Erratum in: JAMA Neurol. 2017 Nov 1;74(11):1381. — View Citation

Murray ME, Senjem ML, Petersen RC, Hollman JH, Preboske GM, Weigand SD, Knopman DS, Ferman TJ, Dickson DW, Jack CR Jr. Functional impact of white matter hyperintensities in cognitively normal elderly subjects. Arch Neurol. 2010 Nov;67(11):1379-85. doi: 10.1001/archneurol.2010.280. — View Citation

Poels MM, Steyerberg EW, Wieberdink RG, Hofman A, Koudstaal PJ, Ikram MA, Breteler MM. Assessment of cerebral small vessel disease predicts individual stroke risk. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1174-9. doi: 10.1136/jnnp-2012-302381. Epub 2012 Aug 23. — View Citation

Sachdev PS, Wen W, Christensen H, Jorm AF. White matter hyperintensities are related to physical disability and poor motor function. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):362-7. — View Citation

Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15. Review. — View Citation

Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8. — View Citation

Vermeer SE, Hollander M, van Dijk EJ, Hofman A, Koudstaal PJ, Breteler MM; Rotterdam Scan Study. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke. 2003 May;34(5):1126-9. Epub 2 — View Citation

Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. Review. — View Citation

Wakefield DB, Moscufo N, Guttmann CR, Kuchel GA, Kaplan RF, Pearlson G, Wolfson L. White matter hyperintensities predict functional decline in voiding, mobility, and cognition in older adults. J Am Geriatr Soc. 2010 Feb;58(2):275-81. doi: 10.1111/j.1532-5415.2009.02699.x. Epub 2010 Jan 26. — View Citation

Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders	baseline
Secondary	Specificity	the specificity of the intelligent system and clinicians to screen for gait disorders	baseline
Secondary	Coincidence	the coincidence of the intelligent system and clinicians to screen for gait disorders	baseline
Secondary	Yoden index	the Yoden index of the intelligent system and clinicians to screen for gait disorders	baseline
Secondary	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	baseline
Secondary	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.	baseline