Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders (DATP-DEG)

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.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders
• Intervention / Treatment: Device: DATP

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31059
      • University Hospital, Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Virginie WOISARD, MD; PHD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Medical device
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 12 558 15; ID-RCB: 2013-A01351-44 (Registry Identifier: ANSM)