Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke

Stroke Clinical Trial

Official title:

Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04868955
• Other study ID #: 2019-00636
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: May 3, 2021

Study information

• Verified date: April 2021
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

Other:
• Oral screen training
Oral screen training (IQoro®) during 13 weeks.

Locations

Country	Name	City	State
Sweden	Vrinnevisjukhuset	Norrkoping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Rebecca Norrman and Elin Rova

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Secondary	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)
Secondary	Change in swallowing function due to oral intake.	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).