Dysphagia, Stroke
Conditions
Brief summary
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.
Interventions
OTHEROral screen training
Oral screen training (IQoro®) during 13 weeks.
Sponsors
Rebecca Norrman and Elin Rova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatient at stroke unit at Vrinnevisjukhuset ward 1, due to stroke. * Patient assessed to have dysphagia (score ≥1 on one of the studied parameters)according to FEES. * Patient who is able to handle IQoro® according to instructions, independently or with support of assistance from relatives or staff.
Exclusion criteria
* Patients with dysphagia of a cause other than stroke. * Patient with impaired cognitive skill, motor and / or language ability that prevents the possibility of performing training with IQoro®, despite possible support from assistance from relatives or staff. * Patient who wishes training with the Muppy oral screen® related to saliva leakage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing function due to secretion in the pharynx. | From baseline to follow up (13 weeks after baseline). | 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. |
| Change in swallowing function due to aspiration and penetration. | From baseline to follow up (13 weeks after baseline). | 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. |
| Change in swallowing function due to residual in the pharynx. | From baseline to follow up (13 weeks after baseline). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The patient's experience of swallowing | From baseline to follow up (13 weeks after baseline) | 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). |
| Change in swallowing function due to oral intake. | From baseline to follow up (13 weeks after baseline). | 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. |
Countries
Sweden
Outcome results
None listed