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| Name | Class |
|---|---|
| Shandong University | OTHER |
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The goal of this clinical study is to compare the effect of favourate taste stimulation of oral cavity and tounge, with sour and traditional single thermal stimulation in post-stroke patients with dysphagia. The main questions it aims to answer are:
Participants screened as post-stroke dysphagia will accept swallowing evaluation and fNIRS test before and after treatment. The treatment include taste stimulation and traditional swallowing training.
Researchers will compare favourate taste stimulation with sour-taste stimulation and single thermal stimulation to see if the swallowing function improved faster and better in favourate taste stimulation group.
Taste perception can help to initiate swallow. Different taste has different impact on swallowing function. Patients with post-stroke dysphagia always have taste impairment and initiation delay of swallowing. In this study, patients with dysphagia after stroke will be recruited and treated with favourate taste stimulation or sour taste stimulation or non-taste stimulation for 2 weeks. Traditional swallowing rehabilitation will be applied base on the status of patients. Before and after the treatment, participants completed swallowing assessment, including quantitative measurement of hyoid displacement, functional oral intake scale (FOIS), dysphagia severity rating scale (DSRS), and standardized swallowing assessment (SSA). In order to understand the effect of taste stimulation on brain network, fNIRS will be conducted.The participants have to conduct these examination three to four weeks after the treatment to undertand the long-time effect of taste stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favourate taste stimulation | Experimental | The swab will be immersed in sugar, salt, citric acid, or paprika mixed with water, and be placed in -18℃ refrigerator. Select the swabs of the participant favourate taste to brush oral cavity and tounge. The stimulation will last two to three minutes one time, and twice for a rehabilitation session, once per day and six days every week, three weeks totally. Swallowing rehabilitation also include standard training that carried out in the department. |
|
| Sour stimulation | Active Comparator | Using sour swab to brush oral cavity and tounge of the participant. The treatment duration and other training method is as same as mentioned above. |
|
| Thermal stimulation | Placebo Comparator | Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favourate taste stimulation | Behavioral | The taste stimulaiton for swallowing is completed with long swab. Taste solution will be prepared with sugar, salt, citric acid, or paprika mixed with water. And the swab will be immersed in the solution and freezed in -18℃ circumstances. Bilateral buccal mucosa,palate and tounge will be brushed. Four swabs will be used in a training session. |
| Measure | Description | Time Frame |
|---|---|---|
| Hyoid displacement | The probe of ultrosound will be placed in the middle of the neck, paralled to the sagittal line. Record the video of participant drinking 1ml water, the distance between hyoid and chin at rest minus distance during hyoid and chin are nerest. Repeated three times, and the mean value is further into analysis. | Befor and after the three-week treatment, and 3 weeks after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| SSA | Standardized swallowing assessment (SSA) include clinical examination, drinking 5mL water test and drinking 60mL water test.lowest score is 18, and the highest score is 46, high score indicationg poor condition. | Befor and after the three-week treatment, and 3 weeks after the treatment. |
| FOIS |
| Measure | Description | Time Frame |
|---|---|---|
| fNIRS | Functional near-infrared spectroscopy (fNIRS) is a tool for measuring the HbO2 concentration to reflect the excitation of cortex. Further analysis can help to explain the network of the brain. | Befor and after the three-week treatment, and 3 weeks after the treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonghui Wang, professor | Contact | 86-18560083581 | yonghuiwangphd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yonghui Wang, professor | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940843 | Background | Nowrin I, Bhattacharyya DS, Saif-Ur-Rahman KM. Community-based interventions to prevent stroke in low-income and middle-income countries: a protocol for a systematic review and meta-analysis. BMJ Open. 2022 Aug 8;12(8):e063181. doi: 10.1136/bmjopen-2022-063181. | |
| 30352222 | Background | Chiang CF, Lin MT, Hsiao MY, Yeh YC, Liang YC, Wang TG. Comparative Efficacy of Noninvasive Neurostimulation Therapies for Acute and Subacute Poststroke Dysphagia: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):739-750.e4. doi: 10.1016/j.apmr.2018.09.117. Epub 2018 Oct 21. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
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| Sour taste stimulation | Behavioral | Using sour swab to brush oral cavity and tounge. |
|
| Thermal stimulation group | Behavioral | Only ice-water swab to brush oral cavity and tounge. |
|
Functional oral intake scale. From one to seven, high score indicate better oral intake function. |
| Befor and after the three-week treatment, and 3 weeks after the treatment. |
| DSRS | The Dysphagia Severity Rating Scale (DSRS) assigns a score to the feeding status achieved by the dysphagic patient depending on the categories of feeding stage for fluid and dietary consumption in addition to the level of dependency required for feeding. The score for each category can vary between 0 and 4 points, and is added to give a composite score. These scores were calculated by a speech and language therapist with special interest in neurogenic dysphagia. SALT:speech and language therapist. | Befor and after the three-week treatment, and 3 weeks after the treatment. |
| Yonghui Wang | Not yet recruiting | Jinan | Shandong | 250012 | China |
|
| 16362509 | Background | Palmer PM, McCulloch TM, Jaffe D, Neel AT. Effects of a sour bolus on the intramuscular electromyographic (EMG) activity of muscles in the submental region. Dysphagia. 2005 Summer;20(3):210-7. doi: 10.1007/s00455-005-0017-x. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |