AI-Based Dysphagia Rehabilitation Program: Development and Validation
16 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dr. Sun
- Número de telefone: 86-10-58122959
- E-mail: ekangfu@163.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Penetration-Aspiration Scale (PAS) Score
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Eating Assessment Tool-10 (EAT-10) Score
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Pengxu Wei, National Research Center for Rehabilitation Techincal Aids
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de agosto de 2026
Primeira postagem (Real)
17 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 120603022006
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
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Não
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