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

• ClinicalTrials.gov Identifier: NCT04868955
• Recruitment Status: Active, not recruiting
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Sponsor: Rebecca Norrman and Elin Rova
• Information provided by (Responsible Party): Rebecca Norrman and Elin Rova, Ostergotland County Council, Sweden

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Dysphagia	Other: Oral screen training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
• Actual Study Start Date: April 26, 2019
• Estimated Primary Completion Date: May 3, 2021
• Estimated Study Completion Date: May 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; Usual care and oral screen (IQoro®) training.	Other: Oral screen training; Oral screen training (IQoro®) during 13 weeks.
No Intervention: Control group; Usual care.

Outcome Measures

Primary Outcome Measures :

1. Change in swallowing function due to secretion in the pharynx. [ Time Frame: 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.

2. Change in swallowing function due to aspiration and penetration. [ Time Frame: 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.

3. Change in swallowing function due to residual in the pharynx. [ Time Frame: 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 Outcome Measures :

1. The patient's experience of swallowing [ Time Frame: 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).
2. Change in swallowing function due to oral intake. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Sweden

Vrinnevisjukhuset

Norrkoping, Ostergotland, Sweden, 60182

Sponsors and Collaborators

Rebecca Norrman and Elin Rova

Investigators

• Principal Investigator: Rebecca U Norrman, Master; Ostergotland County Council, Sweden
• Principal Investigator: Elin AM Rova, Master; Ostergotland County Council, Sweden

More Information

• Responsible Party: Rebecca Norrman and Elin Rova, Speech and language pathologists, Ostergotland County Council, Sweden
• ClinicalTrials.gov Identifier: NCT04868955
• Other Study ID Numbers: 2019-00636
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data will only be reported and shared at group level.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Deglutition Disorders; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases