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Purpose The purpose of the study is to evaluate if training with oral screen IQoro® improves swallowing in patients with dysphagia after stroke.
Method Inpatient from a stroke unit in Sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(FEES) which proves swallowing difficulties (dysphagia) were recruited. The participants were randomise to control- or intervention group. Both groups received usual care. The intervention group were instructed to oral screen (IQoro®) training for 13 weeks. Follow up with FEES was made 13 weeks post of recruitment. The assess with FEES was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Usual care and oral screen (IQoro®) training. |
|
| Control group | No Intervention | Usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral screen training | Other | Oral screen training (IQoro®) during 13 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in swallowing function due to secretion in the pharynx. | Changes in swallowing function based on the parameter secretion in the pharynx. Estimates from "Secretion severity rating scale", 0-3. 0= Normal rating and 3= Secretion in the laryngeal vestibule that are not cleared. Estimates are based on recording from FEES. | From baseline to follow up (13 weeks after baseline). |
| Change in swallowing function due to aspiration and penetration. | Changes in swallowing function based on the parameters aspiration and penetration in the pharynx. Estimates from "Penetration aspiration scale", 0-8. 0= No entry of material into the larynx or trachea, 8= Materials enter the trachea with no attempt to clear. Estimates are based on recording from FEES. | From baseline to follow up (13 weeks after baseline). |
| Change in swallowing function due to residual in the pharynx. | Change in swallowing function due to residual in the pharynx, 0-1. 0= No or a small amount of residual, 1= A pool of residual after the first swallow. Estimates are based on recording from FEES. | From baseline to follow up (13 weeks after baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| The patient's experience of swallowing | The patient estimates its own swallowing ability on the basis of a "Visual analogue scale" (VAS), 0-100. 0= No affected swallowing function and 100= Very affected swallowing function). | From baseline to follow up (13 weeks after baseline) |
| Change in swallowing function due to oral intake. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca U Norrman, Master | Ostergotland County Council, Sweden | Principal Investigator |
| Elin AM Rova, Master | Ostergotland County Council, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrinnevisjukhuset | Norrköping | Östergötland County | 60182 | Sweden |
Data will only be reported and shared at group level.
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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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Change in oral intake estimates from "Functional oral intake scale" (FOIS), 1-7. 1= Nothing by mouth, 7= Total oral diet with no restrictions. Estimates are based on advice the patient received regarding the oral intake. |
| From baseline to follow up (13 weeks after baseline). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |