AI-Based Dysphagia Rehabilitation Program: Development and Validation

Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia

The goal of this clinical study is to learn if an artificial intelligence (AI)-assisted swallowing rehabilitation program can improve swallowing function in adults with dysphagia. It will also learn whether this approach can better detect aspiration (food or liquid entering the airway) and improve eating ability. The main questions it aims to answer are:

Can AI-assisted analysis help identify swallowing treatment parameters that improve swallowing right away?

Does an optimized AI-assisted swallowing treatment work better than standard treatment parameters over 6 weeks?

Can AI using data from sensors detect aspiration accurately?

Researchers will compare swallowing function before and after treatment. They will also compare optimized treatment parameters selected with AI and FEES (a camera-based swallowing test) with standard treatment parameters. In addition, researchers will compare AI model results with FEES findings to see how well the sensors can identify aspiration.

Participants will:

Complete swallowing assessments, including FEES, drinking tests, and swallowing questionnaires.

Have small sensors placed to record muscle activity, sound, oxygen levels, and breathing while swallowing.

Receive swallowing rehabilitation over 6 weeks, with treatment given in 1-week periods. During each period, treatment will be randomly assigned as either optimized parameters or standard parameters.

Complete swallowing assessments after treatment periods to measure changes in swallowing function and eating ability.

Inclusion Criteria:

1. Age ≥ 18 years;
2. Diagnosed with dysphagia, confirmed by clinical screening (e.g., abnormal Water Swallow Test) or instrumental assessment (e.g., FEES);
3. Conscious and alert, without severe cognitive impairment, and capable of understanding instructions and cooperating with swallowing function assessments and rehabilitation therapy;
4. Provision of informed consent, with the informed consent form signed by the patient or their legal representative.

Exclusion Criteria:

1. Age < 18 years;
2. Presence of impaired consciousness, coma, or severe cognitive impairment, rendering the patient unable to understand instructions or cooperate with assessments and treatments;
3. Presence of severe psychiatric disorders, behavioral abnormalities, or severe aphasia/hearing impairment, preventing cooperation with swallowing function assessment and therapy;
4. Presence of severe anatomical abnormalities of the upper respiratory or digestive tract (e.g., laryngeal/esophageal tumors, recent major head and neck surgery), which contraindicate FEES or conventional swallowing therapy;
5. Medically unstable conditions (e.g., severe respiratory distress, hemodynamic instability, acute infection phase), rendering the patient unable to tolerate assessments or rehabilitation therapy;
6. Temporary dysphagia caused by acute, reversible factors (e.g., acute alcohol or drug intoxication);
7. Any other conditions deemed by the investigator as inappropriate for participation in this study.