StrokeNCT04868955
Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
A study testing Oral screen training in people with Stroke and Dysphagia, run by Rebecca Norrman and Elin Rova at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Oral screen training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 26 Apr 2019to 3 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Oral screen training
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral screen trainingOther
Oral screen training (IQoro®) during 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Usual care and oral screen (IQoro®) training. Receives: Other: Oral screen training |
| Control group | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to follow up (13 weeks after baseline).
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.
Measured: From baseline to follow up (13 weeks after baseline).
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.
Measured: From baseline to follow up (13 weeks after baseline).
Secondary outcomes (2)
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).
Measured: From baseline to follow up (13 weeks after baseline)
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.
Measured: From baseline to follow up (13 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start26 Apr 2019
- Primary completion3 May 2021 (estimated)
- Study completion3 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecca Norrman and Elin Rova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecca Norrman and Elin Rova, Ostergotland County Council, Sweden
- Investigators
- Rebecca U Norrman, Master, Principal investigator, Ostergotland County Council, SwedenElin AM Rova, Master, Principal investigator, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868955
- Sponsor's protocol ID
- 2019-00636
- Other IDs
- 2019
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be reported and shared at group level.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
- ClinicalTrials.gov ID
- NCT04868955
- Acronym / sponsor ID
- 2019-00636
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rebecca Norrman and Elin RovaUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 3 May 2021 (estimated)
- Study completion
- 3 May 2021 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Oral screen trainingUsual care and oral screen (IQoro®) training. |
| Control group | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral screen trainingOral screen training (IQoro®) during 13 weeks. | Other | Intervention group |
Primary outcome
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.
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.
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.
2 secondary outcomes
The patient's experience of swallowing
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No. Data will only be reported and shared at group level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca U Norrman, Master principal investigator
Ostergotland County Council, Sweden
Elin AM Rova, Master principal investigator
Ostergotland County Council, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral screen training in people with Stroke and Dysphagia, run by Rebecca Norrman and Elin Rova at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in swallowing function due to secretion in the pharynx. (time frame: From baseline to follow up (13 weeks after baseline).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.