NCT06030323

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 30, 2023

Last Update Submit

September 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of AI models

    Collected during hospitalisation (up to 12 weeks)

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute and sub-acute stroke inpatients

You may qualify if:

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

You may not qualify if:

  • unable to provide informed consent;
  • receiving end-of-life care;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Peter Hartley, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 11, 2023

Study Start

June 24, 2023

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations