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

Not Applicable

Completed

• Conditions: Deglutition Disorders

• Registration Number: NCT02457052
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Primary Completion: 2017-03
• Study Completion: 2018-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional oral intake scale (FOIS)	One month
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.
Quality questionnaire of patient's life	One month	Using Short Form (36) Health Survey (SF-36)
Adult sitting postural control measure (MCPAA)	One month

Trial Locations

Locations (1)

University Hospital, Toulouse; 🇫🇷 Toulouse, Midi-Pyrénées, France