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

Deglutition Disorders Clinical Trial

— DATP-DEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457052
• Other study ID #: 12 558 15
• Secondary ID: ID-RCB: 2013-A01
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease

Intervention

Device:
• DATP
Medical device allowing a custom sitting to help patients with swallowing disorders

Locations

Country	Name	City	State
France	University Hospital, Toulouse	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Functional oral intake scale (FOIS)		One month
Secondary	Adult sitting postural control measure (MCPAA)		One month
Secondary	Quality questionnaire of patient's life	Using Short Form (36) Health Survey (SF-36)	One month