StrokeNCT04164420
Oral Neuromuscular Training in Stroke Patients With Dysphagia
A study testing Oral neuromuscular training and orofacial sensory-vibration and Orofacial sensory-vibration stimulation in people with Stroke and Dysphagia, run by Umeå University at 1 site in Sweden.
Trial summary
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia. Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Oral neuromuscular training and orofacial sensory-vibration and Orofacial sensory-vibration stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2006to Jan 2020
- 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
- First-ever stroke and,
- Pathological timed water swallow test (TWST) at four to five weeks after stroke onset.
Who cannot join
- Inability to cooperate
- Percutaneous endoscopic gastrostomy (PEG)
- Neurological diseases other than stroke
- Known history of dysphagia
- Prominent horizontal overbite
- Hypersensitivity to the acrylate in the oral device.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.
Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.
Read the detailed description
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.
Study design: This 2-center study is an intension-to-treat prospective randomized open-label trial with blinded evaluators (PROBE) design. Evaluations are made at baseline, at end of training, and at late follow-up after a period without training to investigate if any lasting positive training effect was present.
Inclusion criteria: First-ever stroke and a pathological timed water swallow test (TWST) at four to five weeks after stroke onset.
Exclusion criteria: Inability to cooperate, percutaneous endoscopic gastrostomy (PEG), neurological diseases other than stroke, known history of dysphagia, prominent horizontal overbite, hypersensitivity to the acrylate in the oral device.
Study procedure: Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.
Sample size: In order to detect a critical change with a power of 80 %, a sample size of 44 patients (22 in the intervention group and 22 in the control group) that fulfilled the study protocol was required for a type I error of 5 %.
- Being tested
- Oral neuromuscular training and orofacial sensory-vibration, Orofacial sensory-vibration stimulation
- Keywords
- Stroke, Dysphagia, Treatment, Intervention
- 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 neuromuscular training and orofacial sensory-vibrationBehavioural
Oral neuromuscular training is performed by using an oral device. The device is placed pre-dentally behind closed lips, and the participant is sitting in an up-right position. The participant is the instructed to hold the device against a gradually-increasing horizontal pulling force for 5-10 s, whilst trying to resist the force by tightening the lips and pressing the head backward against a head rest.
Orofacial sensory-vibration stimulationBehavioural
All participants in the control group is given orofacial sensory-vibration stimulation by using an electrical toothbrush. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.
| Study group | Role | What they receive |
|---|---|---|
| Oral neuromuscular training and orofacial sensory-vibration | Experimental | Intensive training with oral neuromuscular training and orofacial sensory-vibration stimulation for 5 weeks. The oral neuromuscular training is performed three times per session, and three times daily before eating. Regarding the orofacial sensory-vibration stimulation, the instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal by using a toothbrush. Receives: Behavioral: Oral neuromuscular training and orofacial sensory-vibration |
| Orofacial sensory-vibration stimulation | Active comparator | Orofacial sensory-vibration stimulation by using an electrical toothbrush for five weeks. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal. Receives: Behavioral: Orofacial sensory-vibration stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing ability
Change in swallowing function measured by the timed water swallow test
Measured: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Secondary outcomes (2)
Lip-force (LF)
Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.
Measured: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Swallowing function
Change in structural and functional swallowing ability measured by Videofluoroscopy (VFS) by using the penetration-aspiration scale by Rosenbek. The scale ranges from 0 (normal swallowing function) to 8 (aspiration without sufficient coughing/clearance)
Measured: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study startDec 2006
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Participants are assigned to one of two groups in parallel for five weeks. To either oral neuromuscular training and orofacial sensory-vibration stimulation or to only orofacial sensory-vibration stimulation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Per Wester, Professor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164420
- Sponsor's protocol ID
- 2004:M-435
- Status last verified
- Sep 2019
- First submitted
- 12 Nov 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hagglund P, Hagg M, Levring Jaghagen E, Larsson B, Wester P. Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators. BMC Neurol. 2020 Nov 7;20(1):405. doi: 10.1186/s12883-020-01980-1.
PubMed 33158423
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Neuromuscular Training in Stroke Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT04164420
- Acronym / sponsor ID
- 2004:M-435
- Keywords
- Stroke, Dysphagia, Treatment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Dec 2006 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 15 Nov 2019 (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.
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.
Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.
Detailed description
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.
Study design: This 2-center study is an intension-to-treat prospective randomized open-label trial with blinded evaluators (PROBE) design. Evaluations are made at baseline, at end of training, and at late follow-up after a period without training to investigate if any lasting positive training effect was present.
Inclusion criteria: First-ever stroke and a pathological timed water swallow test (TWST) at four to five weeks after stroke onset.
Exclusion criteria: Inability to cooperate, percutaneous endoscopic gastrostomy (PEG), neurological diseases other than stroke, known history of dysphagia, prominent horizontal overbite, hypersensitivity to the acrylate in the oral device.
Study procedure: Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.
Sample size: In order to detect a critical change with a power of 80 %, a sample size of 44 patients (22 in the intervention group and 22 in the control group) that fulfilled the study protocol was required for a type I error of 5 %.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for five weeks. To either oral neuromuscular training and orofacial sensory-vibration stimulation or to only orofacial sensory-vibration stimulation.
| Arm | Type | Receives |
|---|---|---|
| Oral neuromuscular training and orofacial sensory-vibration | Experimental | Behavioral: Oral neuromuscular training and orofacial sensory-vibrationIntensive training with oral neuromuscular training and orofacial sensory-vibration stimulation for 5 weeks. The oral neuromuscular training is performed three times per session, and three times daily before eating. Regarding the orofacial sensory-vibration stimulation, the instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal by using a toothbrush. |
| Orofacial sensory-vibration stimulation | Active comparator | Behavioral: Orofacial sensory-vibration stimulationOrofacial sensory-vibration stimulation by using an electrical toothbrush for five weeks. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First-ever stroke and,
- Pathological timed water swallow test (TWST) at four to five weeks after stroke onset.
Key exclusion criteria (6 listed)
- Inability to cooperate
- Percutaneous endoscopic gastrostomy (PEG)
- Neurological diseases other than stroke
- Known history of dysphagia
- Prominent horizontal overbite
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 neuromuscular training and orofacial sensory-vibrationOral neuromuscular training is performed by using an oral device. The device is placed pre-dentally behind closed lips, and the participant is sitting in an up-right position. The participant is the instructed to hold the device against a gradually-increasing horizontal pulling force for 5-10 s, whilst trying to resist the force by tightening the lips and pressing the head backward against a head rest. | Behavioural | Oral neuromuscular training and orofacial sensory-vibration |
| Orofacial sensory-vibration stimulationAll participants in the control group is given orofacial sensory-vibration stimulation by using an electrical toothbrush. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal. | Behavioural | Orofacial sensory-vibration stimulation |
Primary outcome
Swallowing ability
Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Change in swallowing function measured by the timed water swallow test
2 secondary outcomes
Lip-force (LF)
Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Swallowing function
Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 33158423Hagglund P, Hagg M, Levring Jaghagen E, Larsson B, Wester P. Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators. BMC Neurol. 2020 Nov 7;20(1):405. doi: 10.1186/s12883-020-01980-1.
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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.
Per Wester, Professor principal investigator
Umeå University
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 neuromuscular training and orofacial sensory-vibration and Orofacial sensory-vibration stimulation in people with Stroke and Dysphagia, run by Umeå University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 25 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Swallowing ability (time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up). 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 NCT04164420, which also lists 1 linked publication.
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 25 Feb 2020.