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

April 27, 2021 updated by: Rebecca Norrman and Elin Rova

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Ostergotland
      • Norrkoping, Ostergotland, Sweden, 60182
        • Vrinnevisjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to follow up (13 weeks after baseline).
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.
From baseline to follow up (13 weeks after baseline).
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.
From baseline to follow up (13 weeks after baseline).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline to follow up (13 weeks after baseline)
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.
From baseline to follow up (13 weeks after baseline).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Anticipated)

May 3, 2021

Study Completion (Anticipated)

May 3, 2021

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will only be reported and shared at group level.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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