Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke

Recruiting

• Conditions: Stroke
• Interventions: Other: Body motion categorisation

• Registration Number: NCT04641286
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

Stroke - still the second commonest cause of death and principal cause of adult neurological disability in the Western World - is characterised by rapid changes over time and marked variability in outcomes. A patient may improve or deteriorate over minutes, and the resultant disability may range from an obvious complete paralysis to subtle, task dependent incoordination of a single limb.

Unlike many other neurological disorders, stroke can be exquisitely sensitive to prompt and intelligently tailored treatment, rewarding innovation in the delivery of care with real-world, tangible impact on patient outcomes. Optimal treatment therefore requires both detailed characterisation of the patient's clinical picture and its pattern of change over time.

Arguably the most important aspect of the patient's clinical picture -- body movement -- remains remarkably poorly documented: quantified only subjectively and at infrequent intervals in the patient's clinical evolution. The combination of artificial intelligence with high-performance computing now enables automatic extraction of a patient's skeletal frame resolved down to major joints, like that of a stick-man, to be delivered simply, safely, and inexpensively, without the use of cumbersome body worn markers. Central to this technology is patient privacy, with the skeletal frame extracted in real time, ensuring no video data, from which patients can be identified, to be stored or transmitted by the device.

Our motion categorisation system -- MoCat -- will be used to study the rapid dynamics of acute stroke, seamlessly embedded in the clinical stream. By quantifying the change in motor deficit over time we shall examine the relationship between these trajectories with clinical outcomes and develop predictive models that can support clinical management and optimise service delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-23
• Study Start: 2021-07-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

• Putative diagnosis of an acute stroke
• Admission on the stroke unit

Exclusion Criteria

• Under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke	Body motion categorisation	Individuals admitted to the Hyper Acute Stroke Unit.

Primary Outcome Measures

Name	Time	Method
Quantify the contribution of joint-level motor dynamics to high-dimensional, predictive models of major clinical outcomes in acute stroke through comparisons of predictive fidelity.	Up to 24 weeks	The predictive fidelity will be quantified by out-of-sample receiver operating characteristic curves for binary variables and mean squared error for real number variables.

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom