Parkinson DiseaseNCT05319795
Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease
A study testing Effortful Swallow Maneuver in people with Parkinson Disease and Dysphagia, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Dysphagia
- What is being tested?
- Effortful Swallow Maneuver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Mar 2022to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years old
- English-speaking
- Able to follow study instructions
- Neurologist confirmed diagnosis of PD
- Hoehn and Yahr scale score of 2 or 3
- Self-report of one or more swallowing or related symptoms:
Show all 10Show fewer
- Difficulty with secretion management
- Coughing at the meal time
- Choking on food
- Respiratory infection in the past 6 months (other than COVID)
Who cannot join
- History of head and neck cancer
- Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy)
- Past medical history of any neurological disease other than PD (e.g. multiple sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke)
- Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions provided in English. This will be determined by the participant's physician prior to referring them to the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2
University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties.
Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD?
Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.
Read the detailed description
The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2 year period. The program will involve daily practice of the effortful swallowing maneuver, with swallowing function assessed before and after the treatment program using videofluoroscopic x-rays.
Expected outcomes: In other populations, the effortful swallow has shown to address two mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness in achieving airway protection and weakness in muscles responsible for transporting food through the throat. The investigators expect that repeated practice of this maneuver by PwPD will lead to improved airway protection and improved clearance of residue from the throat.
- Conditions
- Parkinson Disease, Dysphagia
- Being tested
- Effortful Swallow Maneuver
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effortful Swallow ManeuverBehavioural
Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation.
| Study group | Role | What they receive |
|---|---|---|
| Effortful Swallow Maneuver | Experimental | Adults with a confirmed diagnosis of Parkinson Disease who have radiographically confirmed difficulties with timely airway protection and/or bolus clearance during swallowing. Individuals will complete a 4-week intervention program with two 30-minute sessions of Effortful Swallow (ES) practice daily, 5 days per week. Receives: Behavioral: Effortful Swallow Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time-to-laryngeal-vestibule-closure Thin Liquids
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Penetration-Aspiration Scale Score Thin Liquids
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Pharyngeal Area at Maximum Constriction Thin Liquids
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Total Pharyngeal Residue Thin Liquids
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Penetration-Aspiration Scale Score Mildly Thick Liquids
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Change in Total Pharyngeal Residue Mildly Thick Liquids
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Measured: Post treatment (4 weeks) compared to pre-treatment baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start9 Mar 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Model description
- This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catriona Steele, University Health Network, Toronto
- Investigators
- Catriona M Steele, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319795
- Sponsor's protocol ID
- CAPCR 21-5814
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2022
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT05319795
- Acronym / sponsor ID
- CAPCR 21-5814
- Conditions
- Parkinson Disease, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties.
Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD?
Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.
Detailed description
The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2 year period. The program will involve daily practice of the effortful swallowing maneuver, with swallowing function assessed before and after the treatment program using videofluoroscopic x-rays.
Expected outcomes: In other populations, the effortful swallow has shown to address two mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness in achieving airway protection and weakness in muscles responsible for transporting food through the throat. The investigators expect that repeated practice of this maneuver by PwPD will lead to improved airway protection and improved clearance of residue from the throat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).
| Arm | Type | Receives |
|---|---|---|
| Effortful Swallow Maneuver | Experimental | Behavioral: Effortful Swallow ManeuverAdults with a confirmed diagnosis of Parkinson Disease who have radiographically confirmed difficulties with timely airway protection and/or bolus clearance during swallowing. Individuals will complete a 4-week intervention program with two 30-minute sessions of Effortful Swallow (ES) practice daily, 5 days per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years old
- English-speaking
- Able to follow study instructions
- Neurologist confirmed diagnosis of PD
- Hoehn and Yahr scale score of 2 or 3
Key exclusion criteria (4 listed)
- History of head and neck cancer
- Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy)
- Past medical history of any neurological disease other than PD (e.g. multiple sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke)
- Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions provided in English. This will be determined by the participant's physician prior to referring them to the study.
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 |
|---|---|---|
| Effortful Swallow ManeuverRepeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation. | Behavioural | Effortful Swallow Maneuver |
Primary outcome
Change in Time-to-laryngeal-vestibule-closure Thin Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Penetration-Aspiration Scale Score Thin Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Pharyngeal Area at Maximum Constriction Thin Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Total Pharyngeal Residue Thin Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Penetration-Aspiration Scale Score Mildly Thick Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Change in Total Pharyngeal Residue Mildly Thick Liquids
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8721066Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
- 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.
Catriona M Steele, PhD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effortful Swallow Maneuver in people with Parkinson Disease and Dysphagia, run by University Health Network, Toronto at 2 sites in Canada.
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 10 inclusion and 4 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Time-to-laryngeal-vestibule-closure Thin Liquids (time frame: Post treatment (4 weeks) compared to pre-treatment baseline). The study lists 8 primary outcomes in all. 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 NCT05319795, 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 29 Jul 2024.