Dysphagia, OropharyngealNCT03167892
Oral Screens in Post Stroke Training
A study testing Oral screen in people with Dysphagia, Oropharyngeal, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Stroke is a common disease in older people, and often leads to various degrees of disability. Dysphagia is one such consequence which is associated with aspiration pneumonia and malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but the method is insufficiently evaluated. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dysphagia, Oropharyngeal
- What is being tested?
- Oral screen
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2017to 30 Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second stroke 8-12 months earlier.
- Remaining subjective and objective swallowing difficulties.
- Can eat. Can perform the training by himself/herself or with assistance from someone.
- Natural teeth corresponding category A according to Eichner's index
Who cannot join
- Moderate to severe impressive aphasia: <4.0 points by A-ning
- Moderate to severe cognitive impairment: <23 by MoCA
- Unilateral neglect according to baking tray task
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a common disease in older people, and often leads to various degrees of disability. Dysphagia is one such consequence which is associated with aspiration pneumonia and malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but the method is insufficiently evaluated. Since treatment with an oral screen is easy, relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to assess the feasibility and efficacy of the intervention. Thus, the aim of the present study is to evaluate the effect of daily oral screen training in post-stroke patients with dysphagia.
A randomized controlled clinical study will be performed in subjects who have had a first stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral screen training for 3 months. In total 70 subjects will be randomized to intervention or control. The changes in swallowing capacity is the main outcome, and secondary outcomes are subjective swallowing problems, lip force, chewing function and quality of life.
Improved oral motor function and decreased dysphagia in post-stroke patients will result in an improved quality of life for the individual, and also reduce hospitalization and health care costs.
Read the detailed description
Project plan Population: Patients are recruited from the hospital Stockholms Sjukhem. When discharged, or 6-7 months after stroke, the patients are informed about the study. All positive answers are registered in a coded list. Patients are contacted by the investigators around eight months after the stroke. Patients are included in the study after informed consent, and if the inclusion criteria are fulfilled.
Inclusion criteria: ≥ 65 years of age. First stroke 8-12 months earlier. Remaining subjective and objective swallowing difficulties. Can eat. Can perform the training by himself/herself or with assistance. Natural teeth corresponding to category A according to Eichner's index.
Exclusion criteria: Moderate to severe impressive aphasia: <4.0 points by A-ning (Aphasia screening tool). Moderate to severe cognitive impairment: <23 points by MoCA (Montreal Cognitive Assessment). Unilateral neglect according to the baking tray task.
Procedure: The speech therapist screens the patient with the instruments A-ning, MoCA and Baking tray task. The dentist categorizes their dental status according to Eichner's index. Patients who do not fulfill inclusion criteria are excluded.
The patients are randomized to intervention or control group by central randomization.
At baseline, the patients in the intervention group receive an oral screen (IQoroTM) and get oral and written instructions on how to use it. They are instructed to train three times per day with an effective training time of 1.5 minutes, and to record sessions in a training diary. The patients in the control group do not get any intervention, but will be offered the corresponding training after the end of the study.
At baseline, 1.5 (intervention group only) and 3 months following intervention onset, lip force, swallowing capacity and chewing function are determined. At baseline and 3 months, oro-facial functions are screened with NOT-S and subjective swallowing problems with EAT-10 (Eating assessment tool). In order to relate these specific oral and swallowing instruments to the patient's life situation, we also include the validated instruments ESAS (Edmonton symptom assessment scale) and LiSat (Life Satisfaction) at baseline and 3 months.
Compliance in the intervention group will be evaluated by a training diary. Methods: Lip force is determined with an oral screen in the oral cavity. A hand held digital force gauge is linked to the oral screen with a wire. The patient is instructed to keep the oral screen in place as long as possible while the wire is stretched. The maximum force during tension is recorded three times.
Chewing function is evaluated with regard to bolus formation and mixing efficiency, by the use of a two-colored wax or chewing gum. The shape of the bolus and how well the colors are mixed after 30 chewing cycles is determined by visual assessment and colorimetric measures.
Swallowing capacity test (SCT) is preceded by a water swallowing test with 3-5 tea spoons of water in 4-5 rounds, in order to secure that the SCT is safe to perform. SCT: The patient is instructed to drink 150 ml of water. Swallowing speed is expressed as ml/s. Less than 10 ml/s is considered as an index of abnormal swallowing.
Power: Based on 10 ml/s as the lower limit of normal swallowing speed, we assess that 54 subjects are needed to finish the study. The estimation is made on the basis of a previous study. With 54 subjects, we will be able to determine a 40% higher proportion in the intervention group reaching 10 ml/s in SCT after finishing the training program, with 80% power and significance level 5%. To compensate for expected drop outs, we aim to recruit 35 subjects per group.
It is estimated that it will take about one year to recruit all participants to the study.
- Conditions
- Dysphagia, Oropharyngeal
- Being tested
- Oral screen
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral screenDevice
Oral screen training three times per day with an effective training time of 1.5 minutes, for 3 mo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oral screen Receives: Device: Oral screen |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCT
Swallowing capacity test
Measured: Change from baseline swallowing capacity baseline at 3 mo
Secondary outcomes (5)
Lip force
Lip muscle
Measured: Change from baseline lip force at Month 3
Chewing function
Bolus formation
Measured: Change from baseline bolus formation at Month 3
QoL
Quality of Life by ESAS
Measured: Change from baseline ESAS at Month 3
Chewing function
mixing efficiency
Measured: Change from baseline mixing efficiency at Month 3
QoL
LiSat
Measured: Change from baseline LiSat at Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Sep 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: We did not manage to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunilla Sandborgh Englund, Karolinska Institutet
- Investigators
- Gunilla Sandborgh-Englund, Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167892
- Sponsor's protocol ID
- ACT2017A10
- Status last verified
- Apr 2022
- First submitted
- 11 May 2017
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Appelros P, Karlsson GM, Thorwalls A, Tham K, Nydevik I. Unilateral neglect: further validation of the baking tray task. J Rehabil Med. 2004 Nov;36(6):258-61. doi: 10.1080/16501970410029852.
PubMed 15841602Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.
PubMed 17695052Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
PubMed 1714502Fugl-Meyer AR, Melin R, Fugl-Meyer KS. Life satisfaction in 18- to 64-year-old Swedes: in relation to gender, age, partner and immigrant status. J Rehabil Med. 2002 Sep;34(5):239-46. doi: 10.1080/165019702760279242.
PubMed 12392240Hagg M, Tibbling L. Effect of oral IQoro R and palatal plate training in post-stroke, four-quadrant facial dysfunction and dysphagia: A comparison study. Acta Otolaryngol. 2015 Sep;135(9):962-8. doi: 10.3109/00016489.2015.1042043. Epub 2015 May 7.
PubMed 25947252Moller R, Safa S, Ostberg P. Validation of the Swedish translation of eating assessment tool (S-EAT-10). Acta Otolaryngol. 2016 Jul;136(7):749-53. doi: 10.3109/00016489.2016.1146411. Epub 2016 Feb 29.
PubMed 26924383Hagg M, Tibbling L. Four-quadrant facial function in dysphagic patients after stroke and in healthy controls. Neurol Res Int. 2014;2014:672685. doi: 10.1155/2014/672685. Epub 2014 Mar 4.
PubMed 24724023Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
PubMed 26111925Nathadwarawala KM, Nicklin J, Wiles CM. A timed test of swallowing capacity for neurological patients. J Neurol Neurosurg Psychiatry. 1992 Sep;55(9):822-5. doi: 10.1136/jnnp.55.9.822.
PubMed 1402974Dalum J, Skott P, Akesson E, Persson E, Karlsson A, Habel H, Seiger A, McAllister A, Johansson K, Sandborgh-Englund G. Effect of Oral Screen Training After Stroke-A Randomised Controlled Trial. Gerodontology. 2025 Sep;42(3):380-385. doi: 10.1111/ger.12803. Epub 2024 Dec 5.
PubMed 39636679
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Screens in Post Stroke Training
- ClinicalTrials.gov ID
- NCT03167892
- Acronym / sponsor ID
- ACT2017A10
- Conditions
- Dysphagia, Oropharyngeal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We did not manage to recruit enough participants
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 May 2017 (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.
Stroke is a common disease in older people, and often leads to various degrees of disability. Dysphagia is one such consequence which is associated with aspiration pneumonia and malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but the method is insufficiently evaluated. Since treatment with an oral screen is easy, relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to assess the feasibility and efficacy of the intervention. Thus, the aim of the present study is to evaluate the effect of daily oral screen training in post-stroke patients with dysphagia.
A randomized controlled clinical study will be performed in subjects who have had a first stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral screen training for 3 months. In total 70 subjects will be randomized to intervention or control. The changes in swallowing capacity is the main outcome, and secondary outcomes are subjective swallowing problems, lip force, chewing function and quality of life.
Improved oral motor function and decreased dysphagia in post-stroke patients will result in an improved quality of life for the individual, and also reduce hospitalization and health care costs.
Detailed description
Project plan Population: Patients are recruited from the hospital Stockholms Sjukhem. When discharged, or 6-7 months after stroke, the patients are informed about the study. All positive answers are registered in a coded list. Patients are contacted by the investigators around eight months after the stroke. Patients are included in the study after informed consent, and if the inclusion criteria are fulfilled.
Inclusion criteria: ≥ 65 years of age. First stroke 8-12 months earlier. Remaining subjective and objective swallowing difficulties. Can eat. Can perform the training by himself/herself or with assistance. Natural teeth corresponding to category A according to Eichner's index.
Exclusion criteria: Moderate to severe impressive aphasia: <4.0 points by A-ning (Aphasia screening tool). Moderate to severe cognitive impairment: <23 points by MoCA (Montreal Cognitive Assessment). Unilateral neglect according to the baking tray task.
Procedure: The speech therapist screens the patient with the instruments A-ning, MoCA and Baking tray task. The dentist categorizes their dental status according to Eichner's index. Patients who do not fulfill inclusion criteria are excluded.
The patients are randomized to intervention or control group by central randomization.
At baseline, the patients in the intervention group receive an oral screen (IQoroTM) and get oral and written instructions on how to use it. They are instructed to train three times per day with an effective training time of 1.5 minutes, and to record sessions in a training diary. The patients in the control group do not get any intervention, but will be offered the corresponding training after the end of the study.
At baseline, 1.5 (intervention group only) and 3 months following intervention onset, lip force, swallowing capacity and chewing function are determined. At baseline and 3 months, oro-facial functions are screened with NOT-S and subjective swallowing problems with EAT-10 (Eating assessment tool). In order to relate these specific oral and swallowing instruments to the patient's life situation, we also include the validated instruments ESAS (Edmonton symptom assessment scale) and LiSat (Life Satisfaction) at baseline and 3 months.
Compliance in the intervention group will be evaluated by a training diary. Methods: Lip force is determined with an oral screen in the oral cavity. A hand held digital force gauge is linked to the oral screen with a wire. The patient is instructed to keep the oral screen in place as long as possible while the wire is stretched. The maximum force during tension is recorded three times.
Chewing function is evaluated with regard to bolus formation and mixing efficiency, by the use of a two-colored wax or chewing gum. The shape of the bolus and how well the colors are mixed after 30 chewing cycles is determined by visual assessment and colorimetric measures.
Swallowing capacity test (SCT) is preceded by a water swallowing test with 3-5 tea spoons of water in 4-5 rounds, in order to secure that the SCT is safe to perform. SCT: The patient is instructed to drink 150 ml of water. Swallowing speed is expressed as ml/s. Less than 10 ml/s is considered as an index of abnormal swallowing.
Power: Based on 10 ml/s as the lower limit of normal swallowing speed, we assess that 54 subjects are needed to finish the study. The estimation is made on the basis of a previous study. With 54 subjects, we will be able to determine a 40% higher proportion in the intervention group reaching 10 ml/s in SCT after finishing the training program, with 80% power and significance level 5%. To compensate for expected drop outs, we aim to recruit 35 subjects per group.
It is estimated that it will take about one year to recruit all participants to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Oral screenOral screen |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First or second stroke 8-12 months earlier.
- Remaining subjective and objective swallowing difficulties.
- Can eat. Can perform the training by himself/herself or with assistance from someone.
- Natural teeth corresponding category A according to Eichner's index
Key exclusion criteria (3 listed)
- Moderate to severe impressive aphasia: <4.0 points by A-ning
- Moderate to severe cognitive impairment: <23 by MoCA
- Unilateral neglect according to baking tray task
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 screenOral screen training three times per day with an effective training time of 1.5 minutes, for 3 mo | Device | Intervention |
Primary outcome
SCT
Time frame: Change from baseline swallowing capacity baseline at 3 mo
Swallowing capacity test
5 secondary outcomes
Lip force
Time frame: Change from baseline lip force at Month 3
Chewing function
Time frame: Change from baseline bolus formation at Month 3
QoL
Time frame: Change from baseline ESAS at Month 3
Chewing function
Time frame: Change from baseline mixing efficiency at Month 3
QoL
Time frame: Change from baseline LiSat at Month 3
Results and safety
The study was stopped early (reason given: We did not manage to recruit enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 15841602Appelros P, Karlsson GM, Thorwalls A, Tham K, Nydevik I. Unilateral neglect: further validation of the baking tray task. J Rehabil Med. 2004 Nov;36(6):258-61. doi: 10.1080/16501970410029852.
- Background: PubMed 17695052Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.
- Background: PubMed 1714502Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
- Background: PubMed 12392240Fugl-Meyer AR, Melin R, Fugl-Meyer KS. Life satisfaction in 18- to 64-year-old Swedes: in relation to gender, age, partner and immigrant status. J Rehabil Med. 2002 Sep;34(5):239-46. doi: 10.1080/165019702760279242.
- Background: PubMed 25947252Hagg M, Tibbling L. Effect of oral IQoro R and palatal plate training in post-stroke, four-quadrant facial dysfunction and dysphagia: A comparison study. Acta Otolaryngol. 2015 Sep;135(9):962-8. doi: 10.3109/00016489.2015.1042043. Epub 2015 May 7.
- Background: PubMed 26924383Moller R, Safa S, Ostberg P. Validation of the Swedish translation of eating assessment tool (S-EAT-10). Acta Otolaryngol. 2016 Jul;136(7):749-53. doi: 10.3109/00016489.2016.1146411. Epub 2016 Feb 29.
- Background: PubMed 24724023Hagg M, Tibbling L. Four-quadrant facial function in dysphagic patients after stroke and in healthy controls. Neurol Res Int. 2014;2014:672685. doi: 10.1155/2014/672685. Epub 2014 Mar 4.
- Background: PubMed 26111925Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
- Background: PubMed 1402974Nathadwarawala KM, Nicklin J, Wiles CM. A timed test of swallowing capacity for neurological patients. J Neurol Neurosurg Psychiatry. 1992 Sep;55(9):822-5. doi: 10.1136/jnnp.55.9.822.
- Derived from this study: PubMed 39636679Dalum J, Skott P, Akesson E, Persson E, Karlsson A, Habel H, Seiger A, McAllister A, Johansson K, Sandborgh-Englund G. Effect of Oral Screen Training After Stroke-A Randomised Controlled Trial. Gerodontology. 2025 Sep;42(3):380-385. doi: 10.1111/ger.12803. Epub 2024 Dec 5.
- Individual participant dataSharing planned: No
Related trials for Dysphagia, Oropharyngeal
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
RecruitingPhase 2
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Dysphagia, Stroke
Recruiting
K01 Impacts of Lingual Endurance Exercise
Dysphagia, Dysphagia, Oropharyngeal
RecruitingPhase 2
Adaptive RadioTherapy for OroPharynx Cancer
Oropharynx Cancer, Radiotherapy; Complications
Recruiting
Tongue-strengthening Exercises in People With ALS.
ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
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.
Gunilla Sandborgh-Englund, Prof principal investigator
Karolinska Institutet
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 in people with Dysphagia, Oropharyngeal, run by Karolinska Institutet 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 4 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: stopped early, as of the sponsor's last update on 18 Apr 2022. 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?
The study was stopped early (reason given: We did not manage to recruit enough participants). 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?
SCT (time frame: Change from baseline swallowing capacity baseline at 3 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167892, which also lists 10 linked publications.
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 18 Apr 2022.