Validation of AI Models to Measure Physical Activity After a Stroke

Stroke Clinical Trial

— CaRRAT  

Official title:

Validation and Testing of Artificial Intelligence Models to Measure Physical Activity in Patients Admitted to Hospital Following a Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030323
• Other study ID #: A096458
• Status: Recruiting
• Start date: June 24, 2023
• Est. completion date: June 24, 2024

Study information

• Verified date: September 2023
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Peter Hartley, PhD
• Phone: 441223596317
• Email: peter.hartley[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 24, 2024
• Est. primary completion date: June 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of AI models		Collected during hospitalisation (up to 12 weeks)