An interventional study of Swallowing rehabilitation by rhythmic auditory cue in Oral Festination, Lingual Pumping and Dysphagia, sponsored by Hopital La Musse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Hopital La Musse · Not applicable, Interventional, and Treatment
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:
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 18 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
dysphagic parkinson patient
Behavioral: Swallowing rehabilitation by rhythmic auditory cue
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.
The measurement of the frequency of rolling per minute during a pharyngography
Multiple measurements will be taken to calculate the average.
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).
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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