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Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake

NCT ID: NCT05898139

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-10-13

Brief Summary

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The main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal

Detailed Description

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It is described in the literature that being helped for the meal disrupts the pre-oral phase in the visual and proprioceptive afferences received by the sick person to prepare neurologically the other phases of swallowing. In cases of dysphagia, regardless of the cause, the need for food assistance is correlated with higher mortality and an increased risk of pneumonia. Thus, whether at home or in an establishment, human help is often put in place to facilitate the time of the meal, make it more effective (limitation of the duration of the meal, maximization of the nutritional amounts ingested) and safe (prevention of the occurrence of wrong driving). Our hypothesis is that representations about food and aid at meal times, as well as the attitudes of both the helper and the helped, are factors influencing the realization of an adapted human aid when eating a meal in a dependent person. An observation of a meal during a hospitalization and an interview with the sick person and his caregiver are carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation. A report of the thematic elements identified during the interviews will be proposed for validation by the dyad. This visit can be made during a scheduled appointment in the hospital, by videoconference or at home if the participants do not have access to a videoconference system.

Conditions

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Parkinson Disease Deglutition Disorders

Keywords

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Dysphagia Assistance feeding Parkinson disease Caregivers Mealtime

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Assisting (caregiver) / aided (patient with Parkinsonian syndrome) dyad

The dyad will be filmed during a meal and an interview with the sick person and his caregiver will be carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient with typical or atypical Parkinsonian syndrome, collected in the medical record
* Indication of swallowing disorders or dysphagia, according to item 2.3 chewing and swallowing, part II of the MSD/UPDRS scale or collection in the medical record
* Person dependent on food (according to MDS/UPDRS - food tasks item, part II, 2.4 ≥ 2, to be help to cut food punctually
* Having a usual caregiver present for the meal.
* Affiliated person or beneficiary of a social security scheme.
* Free, informed, written and signed consent by participant and investigator (no later than the day of inclusion and prior to any review required by the research)


* caregiver of the patient for at least 2 months for the taking of meal
* Person with French language to answer the questions of the interview

Exclusion Criteria

* Individuals whose cognitive state does not allow simple questions to be answered, as judged by the neurologist
* Person fed exclusively by enteral nutrition.
* Patient who refuses to be filmed

For caregivers:


* Patient who refuses to be filmed
* Protected patient: under guardianship, trusteeship or other legal protection, deprived of freedom by judicial or administrative decision
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margherita FABBRI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital, Parkinson center

Toulouse, Haute-Garonne, France

Site Status

Countries

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France

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Schindler A, Pizzorni N, Cereda E, Cosentino G, Avenali M, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch E, Bertino G, Clave P, Cortelli P, Eleopra R, Ferrari C, Hamdy S, Huckabee ML, Lopiano L, Marchese-Ragona R, Masiero S, Michou E, Occhini A, Pacchetti C, Pfeiffer RF, Restivo DA, Rondanelli M, Ruoppolo G, Sandrini G, Schapira A, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. Consensus on the treatment of dysphagia in Parkinson's disease. J Neurol Sci. 2021 Nov 15;430:120008. doi: 10.1016/j.jns.2021.120008. Epub 2021 Sep 27.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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RC31/22/0527

Identifier Type: -

Identifier Source: org_study_id

2023-A00393-42

Identifier Type: OTHER

Identifier Source: secondary_id