Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial
August 27, 2026 updated by: 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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhiming Tang
- Phone Number: +86-0757-83161805
- Email: 104237506@qq.com
Study Locations
-
-
Guangdong
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Foshan, Guangdong, China, 528000
- Recruiting
- First People's Hospital of Foshan
-
Contact:
- Zhiming Tang
- Phone Number: +86-18038866461
- Email: 104237506@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: Conventional Tongue-Pressure Resistance Training
Participants will receive conventional tongue-pressure resistance training without digital intelligent pressure monitoring or real-time biofeedback.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Oral Intake Scale (FOIS) Score
Time Frame: Baseline and immediately after completion of the 2-week intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tongue Pressure
Time Frame: Baseline and immediately after completion of the 2-week intervention
|
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.
|
Baseline and immediately after completion of the 2-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2026
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Study Registration Dates
First Submitted
August 27, 2026
First Submitted That Met QC Criteria
August 27, 2026
First Posted (Actual)
September 1, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Research Ethics No.16 (2026)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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