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

Primary Purpose

Stroke, Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Oral screen training
Sponsored by
Rebecca Norrman and Elin Rova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vrinnevisjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Usual care and oral screen (IQoro®) training.

Usual care.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
April 21, 2021
Last Updated
April 27, 2021
Sponsor
Rebecca Norrman and Elin Rova
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1. Study Identification

Unique Protocol Identification Number
NCT04868955
Brief Title
Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
Official Title
Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
May 3, 2021 (Anticipated)
Study Completion Date
May 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca Norrman and Elin Rova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Usual care and oral screen (IQoro®) training.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Other
Intervention Name(s)
Oral screen training
Intervention Description
Oral screen training (IQoro®) during 13 weeks.
Primary Outcome Measure Information:
Title
Change in swallowing function due to secretion in the pharynx.
Description
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.
Time Frame
From baseline to follow up (13 weeks after baseline).
Title
Change in swallowing function due to aspiration and penetration.
Description
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.
Time Frame
From baseline to follow up (13 weeks after baseline).
Title
Change in swallowing function due to residual in the pharynx.
Description
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.
Time Frame
From baseline to follow up (13 weeks after baseline).
Secondary Outcome Measure Information:
Title
The patient's experience of swallowing
Description
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).
Time Frame
From baseline to follow up (13 weeks after baseline)
Title
Change in swallowing function due to oral intake.
Description
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.
Time Frame
From baseline to follow up (13 weeks after baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca U Norrman, Master
Organizational Affiliation
Ostergotland County Council, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elin AM Rova, Master
Organizational Affiliation
Ostergotland County Council, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrinnevisjukhuset
City
Norrkoping
State/Province
Ostergotland
ZIP/Postal Code
60182
Country
Sweden

12. IPD Sharing Statement

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

Learn more about this trial

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

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