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临床试验/NCT07488143
NCT07488143尚未招募不适用

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

University of Leeds0 个研究点目标入组 30 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Number of participants recruited to the study

研究概览

简要总结

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

详细描述

Outline of research This project is designed to assess the feasibility of the STRATIF-AI rehabilitation application (app), alongside its accessibility, usefulness and personalisation to patients. The purpose of the app is to support patients in their recovery from stroke, however, since it is at an early stage of development, the main aims for this study are testing the feasibility of having such an app involved in a patient's recovery and if patients find it useful.

State-of-the-art stratification technology today is based on machine learning (ML) algorithms, trained on large cohort data. This has two main limitations: a) such ML models cannot use all the variety of different data that are generated about a patient, b) stratification is thus only done intermittently, implying outdated and suboptimal care decisions. To remedy this, a new concept and technology - continuous stratification, using the STRATIF-AI platform was developed. In continuous stratification, all data generated about a patient are cumulatively stored in a Personal Data Vault, controlled by the patient. This personal data continuously updates the digital twin platform. The unique potential with the platform comes from the hybrid architecture, combining mechanistic, multiscale, and multi-organ models with ML and bioinformatics.

This technology to allows simulation of patient-specific responses to changes in treatment, and identify changes on intracellular, organ, and whole-body levels, ranging from seconds to years for patients following a stroke. Semantic harmonisation is combined with federated learning to securely re-train the various sub-models when new data become available in one of the cohort databases. This project will explore the use of digital twins in the rehabilitation phase of recovery following stroke and will be carried out in the rehabilitation service at Chapel Allerton Hospital in Leeds. It is one of six simultaneous studies involving eight hospitals across Europe with the aim to refine and validate the models and demonstrate how digital twins can follow patients across different apps, covering all phases of stroke: from prevention to acute treatment and rehabilitation. The scalable platform for continuous stratification forms the foundation for a new interconnected and patient-centric healthcare system.

This project aims to evaluate the feasibility of utilising a novel app to develop a continuous stratification method, using all available data for real-time patient assessment by consolidating patient data into an evolving digital twin. It is hypothesized that the use of this technology compared to standard post-stroke rehabilitation care will improve patient engagement with post-stroke rehabilitation care and create opportunities for future work in the use of digital twins in healthcare.

Background and Rationale Motivation to engage in a rehabilitation programme and concordance with the rehabilitation programme are two major limitations to people's recovery following stroke and which can lead to suboptimal outcomes. A related, and central, problem in all phases of stroke care is that data lie in silos, patients are not provided with their data, and stratification of treatment is made only intermittently. For these reasons, the STRATIF-AI platform, which is based on digital twins - a digital copy of a patient - which facilitates continuous stratification, within and across all phases of stroke care was created. Different studies run by partner hospitals across the consortium will focus on the earlier stages of stroke care such as preventative measures and the acute monitoring of patients. In these studies, data will be collected to allow for the continuous models to be developed. In this clinical study, how patients and medical staff experience the usage of the new platform in rehabilitation will be studied. This is a pilot study, which will examine proof-of-principle, and collect initial feasibility and acceptability data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of participants recruited to the study

时间窗: From enrollment to the end of treatment at 6 weeks

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.

次要结局

  • FIM+FAM(From enrollment to the end of treatment at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Rory O'Connor

Charterhouse Professor of Rehabilitation Medicine

University of Leeds

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