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

NCT ID: NCT04868955

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-26

Study Completion Date

2021-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Usual care and oral screen (IQoro®) training.

Group Type EXPERIMENTAL

Oral screen training

Intervention Type OTHER

Oral screen training (IQoro®) during 13 weeks.

Control group

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral screen training

Oral screen training (IQoro®) during 13 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rebecca Norrman and Elin Rova

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Norrman and Elin Rova

Speech and language pathologists

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rebecca U Norrman, Master

Role: PRINCIPAL_INVESTIGATOR

Ostergotland County Council, Sweden

Elin AM Rova, Master

Role: PRINCIPAL_INVESTIGATOR

Ostergotland County Council, Sweden

Locations

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Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2019-00636

Identifier Type: -

Identifier Source: org_study_id

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