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Recruiting NCT06828679

Using AI Systems to Optimize the Clinical Outcome of Stroke Patients

Trial Parameters

Condition Acute Stroke Intervention
Sponsor Chinese University of Hong Kong
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 65 Years
Max Age 80 Years
Start Date 2025-07-01
Completion 2027-12-31
Interventions
Acupuncturecontrol groupRobotic Training

Brief Summary

This project addresses the imminent challenge of providing adequate motor rehabilitation to a growing number of stroke survivors amidst the ageing population, decreasing age of stroke, and shortage of physical/occupational therapists in Hong Kong through AI and precision rehabilitation. To reduce the socioeconomic burden from the stroke survivors' loss of independence and their care (\>HK$15 billion/year), the efficacy of rehabilitation and efficiency of its delivery must be improved. These goals can be achieved by prescribing them with individually tailored rehabilitations predicted to yield maximal functional return. Defining a predictive model for such personalization remains challenging given the immense heterogeneity of stroke. The investigators aim to build an explainable AI system that predicts a subject's recovery potential and the treatment option that may realize this potential based on multi-modal pre-rehab assessments. Data from clinical, neuroimaging, neurophysiological, and multi-omic evaluations will be collected from stroke survivors (N≥400) before they undergo upper limb rehab with usual care, neuromuscular stimulation, robotic training, or acupuncture. Machine learning-extracted data features will be used to train decision-tree and neural-network AI algorithms for robust predictions. As soon as the model is validated, the investigators will deploy it to implement a personalized rehab program in the community. Our model's ability to predict the optimal intervention from a wide spectrum of input modalities distinguishes ours from previous less-than-accurate models. Our interdisciplinary team of 13 PIs with expertise in neurology, PT/OT, acupuncture, electrical/biomed. engineering, robotics, neuroscience, neuroimaging, multi-omics, data science, and clinical trial management will put us in a world-unique position to execute this project successfully and generate opportunities of interdisciplinary education. In the long run, our prediction system will accelerate marketization of new rehab strategies by facilitating their clinical-trial evaluations in more targeted subjects, thereby leading Hong Kong to be a future global hub of innovative rehabilitation.

Eligibility Criteria

IInclusion Criteria: * Age 65-80 * 1-6 months after onset of a first-time unilateral stroke rostral to midbrain * Moderate-to-severe motor impairment of one upper limb (Fugl-Meyer Assessment for Upper Extremity of 10-50 out of 66); * Able to provide written informed consent; * Detectable electromyographic (EMG) activities in flexor digitorum-flexor carpi radialis and extensor digitorum-extensor carpi ulnaris muscle groups, with EMG from each muscle group exceeding 3 standard deviations above baseline mean. This last criterion is essential for successful NMES training Exclusion Criteria: * Unconscious or bed-bound; * Uncontrollable diabetes; * Anticipated non-adherence to treatment schedule; * On cardiac pacemaker; * Other severe comorbidities (heart/kidney failure, deranged liver function).

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