Dysphagia, Stroke
Conditions
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.
Interventions
DEVICEDigital Intelligent Tongue-Pressure Biofeedback Resistance Training
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.
DEVICEConventional Tongue-Pressure Resistance Training
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.
Sponsors
First People's Hospital of Foshan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake Scale (FOIS) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tongue Pressure | 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. |
Countries
China
Contacts
CONTACTZhiming Tang
Outcome results
None listed