Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial
27. august 2026 opdateret af: Zhiming Tang, First People's Hospital of Foshan
Post-stroke dysphagia is a common complication of stroke and may lead to impaired oral intake, malnutrition, aspiration, and pneumonia.
Reduced tongue strength and tongue pressure are important contributors to impaired swallowing after stroke.
Conventional tongue-pressure resistance training may improve tongue strength, but traditional training provides limited real-time feedback and may be difficult to individualize.This prospective, multicenter, randomized, open-label, parallel-controlled trial will evaluate the effectiveness of digital intelligent tongue-pressure biofeedback resistance training in patients with post-stroke dysphagia.
A total of 80 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group.
Participants in the intervention group will receive digital intelligent tongue-pressure biofeedback resistance training in addition to conventional swallowing rehabilitation, while participants in the control group will receive conventional rehabilitation without the digital biofeedback intervention.
The intervention period will last 2 weeks.Swallowing function will be assessed at baseline and after completion of the intervention.
The primary outcome is the change in Functional Oral Intake Scale (FOIS) score.
Secondary assessments include maximum tongue pressure and quantitative videofluoroscopic swallowing study (VFSS) measures, including oral transit time, Penetration-Aspiration Scale score, and pharyngeal residue.
The study aims to determine whether digital intelligent tongue-pressure biofeedback resistance training provides additional benefits for swallowing function, tongue strength, and swallowing safety in patients with post-stroke dysphagia.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhiming Tang
- Telefonnummer: +86-0757-83161805
- E-mail: 104237506@qq.com
Studiesteder
-
-
Guangdong
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Foshan, Guangdong, Kina, 528000
- Rekruttering
- First People's Hospital of Foshan
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Kontakt:
- Zhiming Tang
- Telefonnummer: +86-18038866461
- E-mail: 104237506@qq.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
Ingen
Beskrivelse
clusion Criteria:
- Subarachnoid hemorrhage, transient ischemic attack, progressive stroke, reversible ischemic neurological deficit, or neurodegenerative disease.
- Unable to complete tongue-pressure measurement or tongue-pressure resistance training, including participants with severe psychiatric disorders, severe cognitive impairment (Mini-Mental State Examination [MMSE] score <18), oral structural abnormalities, or severe oral disease.
- Known allergy or hypersensitivity to materials used in the study device.
- Pregnant or breastfeeding, or planning pregnancy during the study period.
- Participation in another medical device or drug clinical trial within the previous 1 month or current participation in another such trial.
- Any other condition that, in the investigator's judgment, may result in poor compliance or make the participant unsuitable for the 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: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Digital Intelligent Tongue-Pressure Biofeedback Resistance Training
Participants will receive digital intelligent tongue-pressure biofeedback resistance training in addition to conventional swallowing rehabilitation.
The training includes anterior and posterior tongue isometric strengthening and precision biofeedback training.
Strength training is initially set at 80% of the participant's maximum tongue pressure, and endurance training is initially set at 50% of the maximum tongue pressure.
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Digital intelligent tongue-pressure biofeedback resistance training is delivered using a tongue-pressure resistance training device equipped with real-time pressure sensing and visual biofeedback.
Tongue pressure is measured at the anterior, middle, posterior, left, and right regions using a five-point pressure sensor.
Training includes anterior tongue isometric strengthening, posterior tongue isometric strengthening, and precision biofeedback training.
For strength training, the initial target is set at 80% of the participant's maximum tongue pressure, with 20 repetitions per site for 3 sets.
For endurance training, the initial target is set at 50% of the maximum tongue pressure.
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Aktiv komparator: Conventional Tongue-Pressure Resistance Training
Participants will receive conventional tongue-pressure resistance training without digital intelligent pressure monitoring or real-time biofeedback.
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Conventional tongue-pressure resistance training is performed without digital pressure monitoring or real-time visual biofeedback.
Participants perform conventional tongue-strengthening exercises by repeatedly pressing the tongue against the hard palate to strengthen the tongue musculature.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Oral Intake Scale (FOIS) Score
Tidsramme: Baseline and immediately after completion of the 2-week intervention
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The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess the functional level of oral food and liquid intake.
Scores range from 1 (nothing by mouth) to 7 (total oral diet with no restrictions).
Higher scores indicate better functional oral intake.
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Baseline and immediately after completion of the 2-week intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tongue Pressure
Tidsramme: Baseline and immediately after completion of the 2-week intervention
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Tongue pressure will be measured using the tongue-pressure resistance training device.
Participants will perform three tongue-pressure measurement trials, and tongue pressure will be assessed at the anterior, middle, posterior, left, and right regions of the tongue.
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Baseline and immediately after completion of the 2-week intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wang T, Tai J, Hu R, Fan S, Li H, Zhu Y, Wu Y, Wu J. Effect of Tongue-Pressure Resistance Training in Poststroke Dysphagia Patients With Oral Motor Dysfunction: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Dec 1;101(12):1134-1138. doi: 10.1097/PHM.0000000000001998. Epub 2022 Mar 22.
- Aoyagi Y, Ohashi M, Ando S, Inamoto Y, Aihara K, Matsuura Y, Imaeda S, Saitoh E. Effect of Tongue-Hold Swallow on Pharyngeal Contractile Properties in Healthy Individuals. Dysphagia. 2021 Oct;36(5):936-943. doi: 10.1007/s00455-020-10217-9. Epub 2021 Jan 1.
- Kunieda K, Fujishima I, Wakabayashi H, Ohno T, Shigematsu T, Itoda M, Oshima F, Mori T, Ogawa N, Ogawa S. Relationship Between Tongue Pressure and Pharyngeal Function Assessed Using High-Resolution Manometry in Older Dysphagia Patients with Sarcopenia: A Pilot Study. Dysphagia. 2021 Feb;36(1):33-40. doi: 10.1007/s00455-020-10095-1. Epub 2020 Mar 5.
- Song W, Wu M, Wang H, Pang R, Zhu L. Prevalence, risk factors, and outcomes of dysphagia after stroke: a systematic review and meta-analysis. Front Neurol. 2024 Jul 17;15:1403610. doi: 10.3389/fneur.2024.1403610. eCollection 2024.
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 (Faktiske)
5. juni 2026
Primær færdiggørelse (Anslået)
30. december 2028
Studieafslutning (Anslået)
30. december 2028
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
27. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Research Ethics No.16 (2026)
Plan for individuelle deltagerdata (IPD)
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