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NCT Number: NCT04641286

Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location status: Recruiting

Location contact

Lead Stroke Reserach Co-ordinator

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under 18 years of age

Treatment and study plan

Body motion categorisation

Other

All patients will receive passive motion categorisation monitoring

Primary outcomes

  1. 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lead Stroke Research Co-ordionator

CONTACT

[email protected]

02032999000

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • King's College London
  • University College, London

Registry information

Official study title

Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke With Joint-detail, Remote, Body Motion Analysis

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 23, 2020
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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