Validation of AI Models to Measure Physical Activity After a Stroke

NCT ID: NCT06030323

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-24

Study Completion Date

2024-06-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Hartley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cambridge University Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter Hartley, PhD

Role: CONTACT

441223596317

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Peter Hartley, PhD

Role: primary

01223 596317

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A096458

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gait Training for Persons With Stroke
NCT00612300 COMPLETED EARLY_PHASE1