Clinical trial NCT04641286: Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke
Official title: Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke With Joint-detail, Remote, Body Motion Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: University College, London
First posted: 2020-11-23
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the stroke unit with a putative diagnosis of an acute stroke.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: 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.
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Yee Mah
role: STUDY_CHAIR
References: