AI-assisted Continuous Stratification in Neurorehabilitation of Stroke Using Personalized Digital Twins

ConditionStroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Leeds

About this trial

The goal of this clinical trial is to learn if a rehabilitation application on a smartphone, an app, can be used by adults who have had a stroke. The main questions it aims to answer are:

Are people who have had a stroke able to use the app? Is the app useful for people who have had a stroke? Will the app adapt to the needs of the person recovering from a stroke?

Researchers will compare the app to the usual rehabilitation a person receives after a stroke to see if the app can be used as part of a person's rehabilitation.

Participants will:

Use the app every day for 6 weeks Have an assessment with a rehabilitation research doctor before starting using the app and after completing using the app Keep a diary of the exercises that they do using the app

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged over 18

Cognition and physical ability sufficient to use the technology

Diagnosis of ischaemic or haemorrhagic stroke, including subarachnoid haemorrhage

Admitted within 6 months of stroke to an inpatient rehabilitation site in Leeds Teaching Hospitals NHS Trust

Disqualifiers

Previous or concomitant neurological condition

Other major disabling condition prior to stroke

Cognition or physical ability impaired to the extent that the user lacks the capacity to consent to participation in the study or to engage with the technology

Trial design

Design model

Parallel

Treatments tested in this trial

Smartphone rehabilitation application "app"
Device
The study will use a smartphone to deliver the STRATIF-AI app, and wearable technology (i.e. smart watch). Both the smartphone and watch are commercially available. There are no medicinal products administered or studied in this trial.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: InterventionActive comparator 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of participants recruited to the study

In order to determine whether the use of the STRATIF-AI app with digital twin technology improves engagement with rehabilitation and to explore the acceptability of the technology to people who participating in inpatient rehabilitation following stroke we are measuring the number of participants who are recruited to the study.

Time frame

From enrollment to the end of treatment at 6 weeks

Secondary outcomes

FIM+FAM

Functional Independence Measure and Functional Assessment Measure: standardised assessments of function after a stroke for a person participating in a rehabilitation programme

Time frame

From enrollment to the end of treatment at 6 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leeds

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: