Oral FestinationRhythm'nRollNCT06695455
The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients With Dysphagia and Parkinson's Disease
A study testing Swallowing rehabilitation by rhythmic auditory cue in people with Oral Festination and Lingual Pumping, run by Hopital La Musse at 1 site in France.
Trial summary
The main objective of this clinical study is to measure the effect of rhythmic auditory cueing, introduced in rehabilitation with three weekly sessions over a period of 7 weeks, on the frequency of rolling in idiopathic Parkinson's disease patients using pharyngography (swallowing radiography). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Festination, Lingual Pumping, Dysphagia
- What is being tested?
- Swallowing rehabilitation by rhythmic auditory cue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2024to 29 Sep 2026
- 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
- Diagnosis of idiopathic Parkinson's disease established by a neurologist using a DAT SCAN and clinical examination;
- Presence of a swallowing disorder, specifically rolling;
- Patient affiliated with the social security system;
- Patient aged 18 years or older
Who cannot join
- Severe pharyngeal dysphagia (leading to aspiration with nectar and pudding textures);
- Severe cognitive impairment (score <24 on the Mini Mental Parkinson test);
- Known deafness/profound hearing loss;
- Patients under legal protection measures;
- History of reconstructive ENT surgery at the oropharyngeal level;
- Neurological history that could cause a swallowing disorder (e.g., stroke);
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- Patient with a gastrostomy and no oral feeding;
- Ongoing speech therapy for swallowing;
- The patient is included in another research protocol;
- Pregnant women or women suspected of being pregnant;
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital La Musse - La Renaissance Sanitaire
Saint-Sébastien-de-Morsent, Normandy, 27180
About this study
Official title: The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients With Dysphagia and Parkinson's Disease: a Pilot Study
The main objective of this clinical study is to measure the effect of rhythmic auditory cueing, introduced in rehabilitation with three weekly sessions over a period of 7 weeks, on the frequency of rolling in idiopathic Parkinson's disease patients using pharyngography (swallowing radiography). The primary question of this study is:
Does the rhythmic cueing introduced in rehabilitation significantly reduce the frequency of rolling in dysphagic Parkinson's patients?
Read more
The researchers will assess the various stages of swallowing before, after, and 3 months after the rehabilitation protocol, focusing on the oral phase to determine if rhythmic auditory cueing reduces the frequency of rolling.
Participants will be required to:
- Perform three complete assessments (clinical speech therapy examination + pharyngography) before the protocol, after the protocol, and 3 months post-protocol.
- Attend three times per week for 7 weeks at the La Musse hospital to participate in the protocol sessions under the supervision of a speech therapist.
Read the detailed description
Dysphagia can negatively affect the quality of life of patients. Indeed, it leads to difficulties during oral intake (food, drinks, and medications), weight loss, dehydration, malnutrition, and limitations in social activities. Depression is frequently associated with a reduced quality of life in Parkinson's patients with swallowing disorders. Additionally, aspiration pneumonia due to aspiration events is one of the main causes of hospitalization in Parkinson's patients, and it can lead to severe complications and sometimes death.
This clinical study focuses on "rolling," also known as oropharyngeal festination, which is an involuntary, repetitive, anteroposterior movement of the tongue at the level of the soft palate, performed before the food bolus is swallowed.
Rolling is an intrinsically rhythmic movement. The few studies conducted on the subject agree, however, that freezing of gait (difficulties in initiating movement, stopping in front of an obstacle, or navigating around it) and rolling share common pathophysiological mechanisms. Freezing of gait is not limited to a deficit within the locomotor network but rather reflects a more general deficit affecting spatiotemporal coordination across various tasks, just like rolling.
The use of rhythmic auditory cueing (applying rhythmic auditory training to intrinsically rhythmic movements, such as walking, with the aim of achieving more functional movement patterns) has been evaluated in different studies and has proven effective in reducing the frequency of freezing of gait in Parkinson's patients. It thus seems relevant to apply this rehabilitation method to rolling in these same patients to study the effect of auditory cueing on rolling. The secondary objectives will mainly focus on evaluating the effect of auditory cueing on the swallowing abilities of Parkinson's patients, their physical health, and their quality of life.
- Conditions
- Oral Festination, Lingual Pumping, Dysphagia, Swallowing Disorder, PARKINSON DISEASE (Disorder)
- Being tested
- Swallowing rehabilitation by rhythmic auditory cue
- Keywords
- oral festination, lingual pumping, dysphagia, swallowing disorder, parkinson disease, rhythmic auditory cue, rehabilitation, behavioral intervention
- Medical subject headings
- Deglutition Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing rehabilitation by rhythmic auditory cueBehavioural
Three assessments, each spread over two days, will be administered at three different time points during the study: before the experiment (T0), after 7 weeks of the experiment (T1), and 3 months after the intervention (T2). The evaluation will include a pharyngography as well as a clinical assessment of swallowing and rhythmic abilities.
Each subject will be invited to participate in 3 individual rehabilitation sessions per week for 7 weeks, conducted by a speech therapist at La Musse Hospital. Each session will be structured similarly: the subject will be asked to swallow their saliva, followed by a nectar-like texture (IDDSI 2) and a pudding-like texture (IDDSI 4), timed to the rhythm of a metronome. The rhythm will vary throughout the sessions. The goal will be to get as close as possible to the rhythm of a healthy swallow.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm - dysphagic parkinson patient | Experimental | dysphagic parkinson patient Receives: Behavioral: Swallowing rehabilitation by rhythmic auditory cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of the frequency of rolling per minute during a pharyngography
Multiple measurements will be taken to calculate the average.
Measured: Pre-test (before the rehabilitation protocol), Post-test (after the rehabilitation protocol), and Follow-up test (3 months after the completion of the protocol).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start5 Apr 2024
- Primary completion5 Apr 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral FestinationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional research with minimal risks and constraints Prospective, Interventional, Monocentric, without a control group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Collaborators
- France Parkinson Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695455
- Sponsor's protocol ID
- 2023-A02487-38
- Acronym
- Rhythm'nRoll
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients With Dysphagia and Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT06695455
- Acronym / sponsor ID
- Rhythm'nRoll / 2023-A02487-38
- Conditions
- Oral Festination, Lingual Pumping, Dysphagia, Swallowing Disorder, PARKINSON DISEASE (Disorder)
- Keywords
- oral festination, lingual pumping, dysphagia, swallowing disorder, parkinson disease, rhythmic auditory cue, rehabilitation, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Collaborators
- France Parkinson Association
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 19 Nov 2024 (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.
The main objective of this clinical study is to measure the effect of rhythmic auditory cueing, introduced in rehabilitation with three weekly sessions over a period of 7 weeks, on the frequency of rolling in idiopathic Parkinson's disease patients using pharyngography (swallowing radiography). The primary question of this study is:
Does the rhythmic cueing introduced in rehabilitation significantly reduce the frequency of rolling in dysphagic Parkinson's patients?
The researchers will assess the various stages of swallowing before, after, and 3 months after the rehabilitation protocol, focusing on the oral phase to determine if rhythmic auditory cueing reduces the frequency of rolling.
Participants will be required to:
- Perform three complete assessments (clinical speech therapy examination + pharyngography) before the protocol, after the protocol, and 3 months post-protocol.
- Attend three times per week for 7 weeks at the La Musse hospital to participate in the protocol sessions under the supervision of a speech therapist.
Detailed description
Dysphagia can negatively affect the quality of life of patients. Indeed, it leads to difficulties during oral intake (food, drinks, and medications), weight loss, dehydration, malnutrition, and limitations in social activities. Depression is frequently associated with a reduced quality of life in Parkinson's patients with swallowing disorders. Additionally, aspiration pneumonia due to aspiration events is one of the main causes of hospitalization in Parkinson's patients, and it can lead to severe complications and sometimes death.
This clinical study focuses on "rolling," also known as oropharyngeal festination, which is an involuntary, repetitive, anteroposterior movement of the tongue at the level of the soft palate, performed before the food bolus is swallowed.
Rolling is an intrinsically rhythmic movement. The few studies conducted on the subject agree, however, that freezing of gait (difficulties in initiating movement, stopping in front of an obstacle, or navigating around it) and rolling share common pathophysiological mechanisms. Freezing of gait is not limited to a deficit within the locomotor network but rather reflects a more general deficit affecting spatiotemporal coordination across various tasks, just like rolling.
The use of rhythmic auditory cueing (applying rhythmic auditory training to intrinsically rhythmic movements, such as walking, with the aim of achieving more functional movement patterns) has been evaluated in different studies and has proven effective in reducing the frequency of freezing of gait in Parkinson's patients. It thus seems relevant to apply this rehabilitation method to rolling in these same patients to study the effect of auditory cueing on rolling. The secondary objectives will mainly focus on evaluating the effect of auditory cueing on the swallowing abilities of Parkinson's patients, their physical health, and their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional research with minimal risks and constraints Prospective, Interventional, Monocentric, without a control group
| Arm | Type | Receives |
|---|---|---|
| experimental arm - dysphagic parkinson patient | Experimental | Behavioral: Swallowing rehabilitation by rhythmic auditory cuedysphagic parkinson patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's disease established by a neurologist using a DAT SCAN and clinical examination;
- Presence of a swallowing disorder, specifically rolling;
- Patient affiliated with the social security system;
- Patient aged 18 years or older
Key exclusion criteria (10 listed)
- Severe pharyngeal dysphagia (leading to aspiration with nectar and pudding textures);
- Severe cognitive impairment (score <24 on the Mini Mental Parkinson test);
- Known deafness/profound hearing loss;
- Patients under legal protection measures;
- History of reconstructive ENT surgery at the oropharyngeal level;
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 |
|---|---|---|
| Swallowing rehabilitation by rhythmic auditory cueThree assessments, each spread over two days, will be administered at three different time points during the study: before the experiment (T0), after 7 weeks of the experiment (T1), and 3 months after the intervention (T2). The evaluation will include a pharyngography as well as a clinical assessment of swallowing and rhythmic abilities. Each subject will be invited to participate in 3 individual rehabilitation sessions per week for 7 weeks, conducted by a speech therapist at La Musse Hospital. Each session will be structured similarly: the subject will be asked to swallow their saliva, followed by a nectar-like texture (IDDSI 2) and a pudding-like texture (IDDSI 4), timed to the rhythm of a metronome. The rhythm will vary throughout the sessions. The goal will be to get as close as possible to the rhythm of a healthy swallow. | Behavioural | experimental arm - dysphagic parkinson patient |
Primary outcome
The measurement of the frequency of rolling per minute during a pharyngography
Time frame: Pre-test (before the rehabilitation protocol), Post-test (after the rehabilitation protocol), and Follow-up test (3 months after the completion of the protocol).
Multiple measurements will be taken to calculate the average.
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 30 Oct 2026.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing rehabilitation by rhythmic auditory cue in people with Oral Festination and Lingual Pumping, run by Hopital La Musse at 1 site in France.
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 10 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 30 Oct 2026. 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 France. 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?
The measurement of the frequency of rolling per minute during a pharyngography (time frame: Pre-test (before the rehabilitation protocol), Post-test (after the rehabilitation protocol), and Follow-up test (3 months after the completion of the protocol).). 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 30 Oct 2026.