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Validation of AI Models to Measure Physical Activity After a Stroke (CaRRAT)

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ClinicalTrials.gov Identifier: NCT06030323
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Peter Hartley, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:

The research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up.

Sensor location will affect the accuracy of the model and acceptability of the method. The research team are therefore developing algorithms for four different locations.

The purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed).

The research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. After providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. Participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute.


Condition or disease Intervention/treatment
Stroke Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation and Testing of Artificial Intelligence Models to Measure Physical Activity in Patients Admitted to Hospital Following a Stroke
Actual Study Start Date : June 24, 2023
Estimated Primary Completion Date : June 24, 2024
Estimated Study Completion Date : June 24, 2024
Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    This is not an interventional study. The study is classified as 'pre-clinical device development or performance testing'. The purpose of the study is to develop and validate the AI models using data collected from people affected by stroke in a hospital environment, to test the accuracy of the optimised models, and to ascertain patient preference for sensor location.

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and specificity of AI models [ Time Frame: Collected during hospitalisation (up to 12 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute and sub-acute stroke inpatients
Criteria

Inclusion Criteria:

  • admitted to hospital with a diagnosis of an acute stroke.

Exclusion Criteria:

  • unable to provide informed consent;
  • receiving end-of-life care;
  • the consultant in charge of their care disagrees with their inclusion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030323


Contacts
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Contact: Peter Hartley, PhD 441223596317 peter.hartley@nhs.net

Locations
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United Kingdom
Cambridge University Hospital NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Peter Hartley, PhD    01223 596317    peter.hartley@nhs.net   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
More Information
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Responsible Party: Peter Hartley, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06030323    
Other Study ID Numbers: A096458
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases