Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders

Study Overview
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Brief Summary
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When the seat is a vehicle for disabled person, postural adaptation methodology is known and, on prescription, there is possibility of financial support for technical posture assists. For people who use a standard seat, a chair for example, there is no satisfactory existing hardware. A transportable customisable and scalable sitting positioning device (DATP device), to be placed on a standard seat, is a solution that might fit in the home, in specialized foster homes or in institutions for the elderly. Such a device has been developed but earnings on swallowing disorders have to be validated.

Official Title
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Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders

Conditions
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Deglutition Disorders

Intervention / Treatment
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* Device: DATP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Present a swallowing disorder authenticated by a score Dysphagia Handicap Index above 11 Postural disorder authenticated by a score greater than 0 to at least 1 of the following 3 items to MCPAA: retroversion, obliquity and rotation of the pelvis Autonomy Conservation compatible with the use of different seats including standard seats Signing of informed consent Exclusion Criteria: Postural disorder requiring the use of only one type of installation (wheelchair or hull) Spinal stiffness or non-reducible hips (spondylitis, osteosynthesis rod) Not included anthropometric dimensions between: Basin with between 39 and 50 cm femoral length between 42 and 52 cm tibial length between 39 and 44 cm (46.5 with femoral recharge), measured with the shoes. Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DATP +<br>Introduction of a device allowing a custom sitting to help patients with swallowing disorders . | Device: DATP<br>* Medical device allowing a custom sitting to help patients with swallowing disorders<br>|
| No Intervention: DATP -<br>No introduction of a device allowing a custom sitting to help patients with swallowing disorders . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in laryngeal movement during swallowing | Compare the laryngeal movement during swallowing in dysphagic population with DATP device compare to a population without device after one month of care. At Visit 1, patients were included and randomized 1 month later the patients in both groups will be invited for specific education session positioning. The introduction of the device will be carried out before the meeting for patients DATP + group, which will include a training session in the use of DATP. Patients who have the DATP will be contacted by telephone within the first 15 days to verify compliance with the use of the device. All patients returned 1 month for the last visit. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Swallowing Safety Scale | The secondary outcomes are to evaluate the impact on other characteristics of swallowing, the posture, the acceptability of the device and the quality of life. Comparison before and after the treatment of dysphagia population with DATP compared to a population dysphagia. | One month | 
| Functional oral intake scale (FOIS) |  | One month | 
| Adult sitting postural control measure (MCPAA) |  | One month | 
| Quality questionnaire of patient's life | Using Short Form (36) Health Survey (SF-36) | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical device