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

NCT07488143 | Not Yet Recruiting

• 2 other identifiers: 362764101080875
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stroke

Keywords

Rehabilitation; Stroke; Digital twin

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

• FIM+FAM

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Use of the smartphone rehabilitation application "app"

Device: Smartphone rehabilitation application "app"

Usual care

NO INTERVENTION

Usual rehabilitation care

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Rory J O'Connor, MD

CONTACT

44 113 3924655; medrjo@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charterhouse Professor of Rehabilitation Medicine

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: March 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Information will be available from 01/07/2027 to 30/06/2032
• Access Criteria: It is envisaged that datasets will be made available mainly under Creative Commons license CC BY 4.0. It gives permission to users to freely share, modify, and use the data, subject only to full credit to the author(s) of the dataset. In general, data will be made openly available to validate the research results immediately at the time of the publication of the corresponding scientific peer-reviewed papers, although some datasets can be made publicly available without the need of publishing a related article, but providing a full description, including quality assurance processes. If datasets are underlying data of public deliverables, an embargo period will be applied to allow full exploitation of research results by the STRATIF-AI partners. Full citation of datasets will be given in STRATIF-AI dissemination means as they will be made available through institutional or public data repositories for long-term/permanent deposit will be given also in STRATIF-AI.