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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Change from baseline in laryngeal movement during swallowing [ Time Frame: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NIH Swallowing Safety Scale [ Time Frame: 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) [ Time Frame: One month ]
  • Adult sitting postural control measure (MCPAA) [ Time Frame: One month ]
  • Quality of life [ Time Frame: One month ]
    Using SF-36 scale


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: April 9, 2015
Date Started: October 2014
Date Completion: October 2016
Last Updated: May 26, 2015
Last Verified: May 2015