Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial

NCT07798401 | Recruiting Phase 2

• 1 other identifier: Research Ethics No.16 (2026)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia; Stroke

Outcome Measures

Primary Outcomes (1)

• Functional Oral Intake Scale (FOIS) Score

  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.

  Baseline and immediately after completion of the 2-week intervention

Secondary Outcomes (1)

• Tongue Pressure

  Baseline and immediately after completion of the 2-week intervention

Study Arms (2)

Digital Intelligent Tongue-Pressure Biofeedback Resistance Training

EXPERIMENTAL

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.

Device: Digital Intelligent Tongue-Pressure Biofeedback Resistance Training

Conventional Tongue-Pressure Resistance Training

ACTIVE COMPARATOR

Participants will receive conventional tongue-pressure resistance training without digital intelligent pressure monitoring or real-time biofeedback.

Device: Conventional Tongue-Pressure Resistance Training

Interventions

Digital Intelligent Tongue-Pressure Biofeedback Resistance Training DEVICE

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.

Digital Intelligent Tongue-Pressure Biofeedback Resistance Training

Conventional Tongue-Pressure Resistance Training DEVICE

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.

Conventional Tongue-Pressure Resistance Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

clusion Criteria: 1. Subarachnoid hemorrhage, transient ischemic attack, progressive stroke, reversible ischemic neurological deficit, or neurodegenerative disease. 2. 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. 3. Known allergy or hypersensitivity to materials used in the study device. 4. Pregnant or breastfeeding, or planning pregnancy during the study period. 5. Participation in another medical device or drug clinical trial within the previous 1 month or current participation in another such trial. 6. Any other condition that, in the investigator's judgment, may result in poor compliance or make the participant unsuitable for the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• First People's Hospital of Foshan: lead

Study Sites (1)

First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 35320813 BACKGROUND

• 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.

  PMID: 33386483 BACKGROUND

• 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.

  PMID: 32140906 BACKGROUND

• 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.

  PMID: 39087010 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhiming Tang

CONTACT

+86-0757-83161805; 104237506@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)