AI-Based Dysphagia Rehabilitation Program: Development and Validation
16. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dr. Sun
- Telefonnummer: 86-10-58122959
- E-mail: ekangfu@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Penetration-Aspiration Scale (PAS) Score
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Eating Assessment Tool-10 (EAT-10) Score
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Pengxu Wei, National Research Center for Rehabilitation Techincal Aids
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
11. august 2026
Først indsendt, der opfyldte QC-kriterier
11. august 2026
Først opslået (Faktiske)
17. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 120603022006
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