AI-Based Dysphagia Rehabilitation Program: Development and Validation
16 août 2026 mis à jour par: Pengxu Wei, National Research Center for Rehabilitation Technical Aids
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dr. Sun
- Numéro de téléphone: 86-10-58122959
- E-mail: ekangfu@163.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Age ≥ 18 years;
- Diagnosed with dysphagia, confirmed by clinical screening (e.g., abnormal Water Swallow Test) or instrumental assessment (e.g., FEES);
- Conscious and alert, without severe cognitive impairment, and capable of understanding instructions and cooperating with swallowing function assessments and rehabilitation therapy;
- Provision of informed consent, with the informed consent form signed by the patient or their legal representative.
Exclusion Criteria:
- Age < 18 years;
- Presence of impaired consciousness, coma, or severe cognitive impairment, rendering the patient unable to understand instructions or cooperate with assessments and treatments;
- Presence of severe psychiatric disorders, behavioral abnormalities, or severe aphasia/hearing impairment, preventing cooperation with swallowing function assessment and therapy;
- 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;
- Medically unstable conditions (e.g., severe respiratory distress, hemodynamic instability, acute infection phase), rendering the patient unable to tolerate assessments or rehabilitation therapy;
- Temporary dysphagia caused by acute, reversible factors (e.g., acute alcohol or drug intoxication);
- Any other conditions deemed by the investigator as inappropriate for participation in this study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Optimized methods
|
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.
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.
|
|
Comparateur actif: Standard methods
|
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.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Penetration-Aspiration Scale (PAS) Score
Délai: Baseline to 6 weeks.
|
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
Délai: Baseline to 6 weeks
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Eating Assessment Tool-10 (EAT-10) Score
Délai: Baseline to 6 weeks
|
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
Délai: Baseline to 6 weeks
|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Pengxu Wei, National Research Center for Rehabilitation Techincal Aids
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
11 août 2026
Première soumission répondant aux critères de contrôle qualité
11 août 2026
Première publication (Réel)
17 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 120603022006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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