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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: Neuromuscular electrical stimulation for swallowing; Diagnostic test: Multi-sensor swallowing screening for dysphagia

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Sun; Phone Number: 86-10-58122959; Email: ekangfu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimized methods	Device: Neuromuscular electrical stimulation for swallowing; Participants receive neuromuscular electrical stimulation (NMES) applied to swallowing-related muscles as part of swallowing rehabilitation. The stimulation parameters are individualized using an AI-assisted optimization process. The AI model analyzes swallowing assessment data, including FEES findings and multi-sensor signals, to select parameters expected to improve swallowing. The selected parameters are then applied. This intervention differs from conventional methods because the stimulation parameters are not selected solely by clinician experience, but are optimized by an AI-assisted system based on the participant's swallowing assessment results.; Diagnostic test: Multi-sensor swallowing screening for dysphagia; Participants undergo a multi-sensor screening test for dysphagia. During swallowing, signals are collected from multiple sensors, such as surface electromyography, acoustic sensors, oxygen saturation, and respiratory sensors. The signals are analyzed using AI-assisted algorithms to identify patterns associated with swallowing impairment and aspiration risk. This approach provides objective, quantitative swallowing assessment and may be compared with FEES. It differs from conventional bedside screening and FEES by combining multiple physiological signals.
Active Comparator: Standard methods	Device: Neuromuscular electrical stimulation for swallowing; Participants receive neuromuscular electrical stimulation (NMES) applied to swallowing-related muscles as part of swallowing rehabilitation. The stimulation parameters are individualized using an AI-assisted optimization process. The AI model analyzes swallowing assessment data, including FEES findings and multi-sensor signals, to select parameters expected to improve swallowing. The selected parameters are then applied. This intervention differs from conventional methods because the stimulation parameters are not selected solely by clinician experience, but are optimized by an AI-assisted system based on the participant's swallowing assessment results.; Diagnostic test: Multi-sensor swallowing screening for dysphagia; Participants undergo a multi-sensor screening test for dysphagia. During swallowing, signals are collected from multiple sensors, such as surface electromyography, acoustic sensors, oxygen saturation, and respiratory sensors. The signals are analyzed using AI-assisted algorithms to identify patterns associated with swallowing impairment and aspiration risk. This approach provides objective, quantitative swallowing assessment and may be compared with FEES. It differs from conventional bedside screening and FEES by combining multiple physiological signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Penetration-Aspiration Scale (PAS) Score	The PAS is an 8-point scale derived from FEES (Flexible Endoscopic Evaluation of Swallowing) to quantify the depth and clearance of material entering the airway. A score of 1 indicates normal swallowing, while 8 indicates silent aspiration.	Baseline to 6 weeks.
Change in Pharyngeal Residue Severity	Residue was assessed via FEES using the Yale Pharyngeal Residue Severity Rating Scale. This is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (1: none, 2: trace, 3: mild, 4: moderate, and 5: severe), used to quantify post-swallow residue in the valleculae and pyriform sinuses across different consistencies.	Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eating Assessment Tool-10 (EAT-10) Score	A self-administered questionnaire assessing the severity of swallowing disorder symptoms and their impact on quality of life. Scores range from 0 to 40, with higher scores indicating worse symptoms.	Baseline to 6 weeks
Change in Functional Oral Intake Scale (FOIS) Score	Oral intake status was assessed using a 7-point scale (Functional Oral Intake Scale [FOIS]), ranging from nothing by mouth (Level 1: most impaired) to a total oral diet with no restrictions (Level 7: most functional).	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: National Research Center for Rehabilitation Technical Aids
• Investigators: Principal Investigator: Pengxu Wei, National Research Center for Rehabilitation Techincal Aids

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 16, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: 120603022006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No