DysphagiaPhase 2NCT07798401
Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial
A Phase 2 study testing Digital Intelligent Tongue-Pressure Biofeedback Resistance Training and Conventional Tongue-Pressure Resistance Training in people with Dysphagia and Stroke, run by First People's Hospital of Foshan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Digital Intelligent Tongue-Pressure Biofeedback Resistance Training and Conventional Tongue-Pressure Resistance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2026to 30 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First People's Hospital of Foshan
Foshan, Guangdong, 528000
Zhiming Tang, +86-18038866461, 104237506@qq.com
About this study
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.
- Being tested
- Digital Intelligent Tongue-Pressure Biofeedback Resistance Training, Conventional Tongue-Pressure Resistance Training
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intelligent Tongue-Pressure Biofeedback Resistance TrainingDevice
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.
Conventional Tongue-Pressure Resistance TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional Tongue-Pressure Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 2-week intervention
Secondary outcomes (1)
Tongue Pressure
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.
Measured: Baseline and immediately after completion of the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start5 Jun 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Tang, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798401
- Sponsor's protocol ID
- Research Ethics No.16 (2026)
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35320813Aoyagi 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.
PubMed 33386483Kunieda 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.
PubMed 32140906Song 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.
PubMed 39087010