DysphagiaNCT04595643
Outpatient Swallowing Therapy for Subjects With Neurological Illness
A study testing Combination of different dysphagia training modalities in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Combination of different dysphagia training modalities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 31 Dec 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
- Neurological illness
- Living in the Region of central Jutland
- FEDSS score 2-6
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Region of Central Jutland, 8450
About this study
Official title: Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study
Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided.
The objective is to investigate the effect of a specialized outpatient dysphagia unit for subjects with dysphagia following neurological illness. Occupational therapists from the outpatient dysphagia unit will train with subjects for 2-3 weeks, and supervise furter training provided by health care staff in the municipalities.
- Conditions
- Dysphagia
- Being tested
- Combination of different dysphagia training modalities
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of different dysphagia training modalitiesOther
Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.
| Study group | Role | What they receive |
|---|---|---|
| Specialized dysphagia treatment | Experimental | Dysphagia treatment is provided by occupational therapists specialized in dysphagia. Receives: Other: Combination of different dysphagia training modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.
Measured: Baseline and 14 days follow-up
Change in Functional Oral Intake Scale (FOIS)
Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.
Measured: Baseline, immediately after the intervention, and 14 days follow-up
Secondary outcomes (4)
Change in Penetration Aspiration Scale (PAS)
Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.
Measured: Baseline and 14 days follow-up
Change in The Yale Pharyngeal Residue Severity Rating Scale
Assessment of residue location and amount of residue. Two subscales with scores ranging 1-5. Higher scores mean worse outcome.
Measured: Baseline and 14 days follow-up
Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)
Clinical examination of swallowing function. Yes or no to initiation of oral intake (binary outcome).
Measured: Baseline, immediately after the intervention, and 14 days follow-up
Dysphagia Handicap Index (DHI)
Questionnaire on experience of dysphagia. 25 items with a toal score ranging 0-100. Higher scores mean worse outcome. Also measures overall severity with scores ranging 1-7. Higher scores means worse outcome.
Measured: Baseline, immediately after the intervention, and 14 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, PhD, Principal investigator, Hammel Neurorehabilitation Centre and Univeristy Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595643
- Sponsor's protocol ID
- 1-10-72-182-20
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study
- ClinicalTrials.gov ID
- NCT04595643
- Acronym / sponsor ID
- 1-10-72-182-20
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Oct 2020 (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.
Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided.
The objective is to investigate the effect of a specialized outpatient dysphagia unit for subjects with dysphagia following neurological illness. Occupational therapists from the outpatient dysphagia unit will train with subjects for 2-3 weeks, and supervise furter training provided by health care staff in the municipalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specialized dysphagia treatment | Experimental | Other: Combination of different dysphagia training modalitiesDysphagia treatment is provided by occupational therapists specialized in dysphagia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neurological illness
- Living in the Region of central Jutland
- FEDSS score 2-6
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Combination of different dysphagia training modalitiesNeuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies. | Other | Specialized dysphagia treatment |
Primary outcome
Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
Time frame: Baseline and 14 days follow-up
The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.
Change in Functional Oral Intake Scale (FOIS)
Time frame: Baseline, immediately after the intervention, and 14 days follow-up
Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.
4 secondary outcomes
Change in Penetration Aspiration Scale (PAS)
Time frame: Baseline and 14 days follow-up
Change in The Yale Pharyngeal Residue Severity Rating Scale
Time frame: Baseline and 14 days follow-up
Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)
Time frame: Baseline, immediately after the intervention, and 14 days follow-up
Dysphagia Handicap Index (DHI)
Time frame: Baseline, immediately after the intervention, and 14 days 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 22 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Jesper Fabricius, PhD principal investigator
Hammel Neurorehabilitation Centre and Univeristy Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of different dysphagia training modalities in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
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 1 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 22 Jan 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 Denmark. 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?
Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) (time frame: Baseline and 14 days follow-up). The study lists 2 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 22 Jan 2021.