Deglutition Disorders
Conditions
Keywords
Medical device
Brief summary
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.
Interventions
DEVICEDATP
Medical device allowing a custom sitting to help patients with swallowing disorders
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in laryngeal movement during swallowing | One month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIH Swallowing Safety Scale | One month | 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. |
| Functional oral intake scale (FOIS) | One month | — |
| Adult sitting postural control measure (MCPAA) | One month | — |
| Quality questionnaire of patient's life | One month | Using Short Form (36) Health Survey (SF-36) |
Countries
France
Outcome results
None listed