Using AI Systems to Optimize the Clinical Outcome of Stroke Patients

NCT06828679 | Recruiting

• 2 other identifiers: STG-001STG1/M-401/24-N
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke Intervention; Acute Stroke; Acute Ischemic Stroke

Keywords

stroke; motor neuroscience; MRI; rehabilitation; muscle coordination; electromyography; Artificial intelligence; Transcranial Magnetic Stimulation; neuroimaging; Proteomics; Metabolomics; Genomics; Epigenomics; Acupuncture; biomarkers; muscle synergies

Outcome Measures

Primary Outcomes (3)

• Surface EMG Recordings

  Surface EMG electrodes may be conveniently used to record myoelectric activities of multiple muscles during voluntary movement. This data can reveal the muscle coordination patterns utilized by the motor system for control. We have previously shown that muscle synergies, building blocks of muscle coordination decomposed from EMG using machine learning, may serve as markers of post-stroke functional assessment and prognosis. Here, we will record EMG from 16 affected-side muscles during 8-10 activities of daily living.

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• Kinematic recordings

  We will utilize motion capture technology to analyze stroke patients' movements by attaching reflective markers to their bodies. This setup will allow us to record their performance during 8 to 10 activities of daily living. The collected data will enable us to evaluate joint angles and movement patterns, providing insights into functional capabilities and informing rehabilitation strategies.

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• Cortico-muscular Coherence (CMC) from Electroencephalography (EEG) and EMG

  The CMC is a measure, derived from concurrent EEG and EMG during movement, that quantifies the overall capacity of the cortex to coordinate activities of multiple muscles. After stroke, the CMC between different brain regions and muscles are altered. Given that the structural connectome may predict recovery potential, it is likely that CMC should carry some predictive power. We will record EEG (64 channels) during the EMG assessment described above. The CMC between each EEG channel and each muscle may serve as inputs to the prediction system.

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

Secondary Outcomes (6)

• Fugl-Meyer Assessment for Upper Extremity

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• Modified Tardieu Scale

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• National Institutes of Health Stroke Scale

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• Brunnstrom Stages

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

• Wolf Motor Function Test

  From Pre-assessment stages (A0) to follow up sessions (A2), the whole time frame will be within 6 months

Study Arms (4)

Rehabilitation Control Group

ACTIVE COMPARATOR

Subacute stroke survivors in this group, patients will receive usual rehab care only.

Other: control group

Acupuncture Group

ACTIVE COMPARATOR

Subacute stroke survivors in this group, patients will receive usual rehab care plus acupuncture

Other: Acupuncture

Robotic Training Group

ACTIVE COMPARATOR

Subacute stroke survivors in this group, patients will receive usual rehab care plus robotic training

Device: Robotic Training

NMES Group

ACTIVE COMPARATOR

Subacute stroke survivors in this group, patients will receive usual rehab care plus Neuromuscular Electrical Stimulation (NMES)

Device: Neuromuscular Electrical Stimulation Group

Interventions

Acupuncture OTHER

Patients will receive 12 weeks of acupuncture with 3 half-hour sessions weekly. Acupoints will include (1) a basic formula of 8 Bo's abdomen acupoints (paretic side, 0.5cm depth vertically) \[66\]; (2) 12 conventional acupoints (bilateral, opposite to paretic side first, 1-4 cm depth vertically) \[67\]; and (3) 3 scalp acupoints (opposite to paretic side, 0.5-cm depth at 15-30 degrees) \[68\]At most 3 additional supplementary acupoints will be included, depending on the clinician's professional judgement. Sterile needles will be used after skin disinfection. Manual rotating manipulation \[69\] will be performed every 10 minutes on the conventional acupoints to achieve De-qi sensation \[70\]. Abdomen and scalp acupoints do not require De-qi. Subjects will be monitored throughout the course of therapy with face-to-face assessments by blinded and trained clinicians after 0, 4, 8, 12 weeks of intervention. Clinical scales will also be recorded at 0 (A0), 8 (A½), and 12 weeks (A1).

Acupuncture Group

control group OTHER

Subjects in this group will receive the typical post-stroke care offered to stroke survivors of Hong Kong. This care emphasizes restoring function and independence through a comprehensive approach. Physical therapy focuses on improving mobility with exercises and training; occupational therapy helps patients relearn essential daily living skills, facilitating a smooth transition back to everyday life. Speech therapy is integral for addressing communication challenges, and psychological support is provided to help patients manage the emotional impact of stroke. All subjects will receive the above care for 8 weeks (≥3 hourly sessions per week). Clinical scales will be recorded at 0 (A0), 4 (A½), and 8 weeks (A1).

Rehabilitation Control Group

Robotic Training DEVICE

For this treatment group, CMC (corticomuscular coherence)-EMG-triggered control will assist wrist extension with hand open and wrist flexion with hand close alternately by mechanical pneumatic support \[60\]. During wrist-hand extension, the pneumatic fingers will assist a hand-open motion with constant inflation till the inner pressure reaches 90kPa; during the wrist-hand flexion, the pneumatic fingers will deflate constantly to assist a hand-close motion. To trigger ENMS assistance, two criteria must be met: (1) the average EMGs of target muscles exceed a pre-defined threshold, and (2) a significant CMC peak value with peak frequency in the beta band is captured. Here, the target muscle groups will be the extensor digitorum and extensor carpi ulnaris (ED-ECU) and flexor digitorum and flexor carpi radialis (FD-FCR), and the EMG and CMC will be evaluated during sustained contraction of these muscles over a 3-sec window.

Robotic Training Group

Neuromuscular Electrical Stimulation Group DEVICE

For this treatment group, constant NMES (70V, 40Hz, 0-300µs square wave bursts \[63\]) will be delivered to the ED-ECU and FD-FCR muscles to assist in wrist-hand extension and flexion, respectively. The pulse width of NMES will be individually adjusted to achieve the maximum muscle contraction with the minimum stimulation intensity. The control strategy of CMC-EMG-triggered NMES will be the same as that used in the robot.

NMES Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-80
• 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

You may not qualify if:

• Unconscious or bed-bound;
• Uncontrollable diabetes;
• Anticipated non-adherence to treatment schedule;
• On cardiac pacemaker;
• Other severe comorbidities (heart/kidney failure, deranged liver function).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: collaborator
• City University of Hong Kong: collaborator
• Hong Kong Baptist University: collaborator
• The University of Western Australia: collaborator
• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Sha Tin, 852, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Acupuncture Therapy; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Yat Sing Kelvin Lau, MSc

CONTACT

85296363365; yatsingkelvinlau@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: February 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

HK (1)