Back to resultsImpact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders (DATP-DEG)
Primary Purpose
Deglutition Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DATP
Sponsored by
About this trial
This is an interventional supportive care trial for Deglutition Disorders focused on measuring Medical device
Eligibility Criteria
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
Sites / Locations
- University Hospital, Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DATP +
DATP -
Arm Description
Introduction of a device allowing a custom sitting to help patients with swallowing disorders .
No introduction of a device allowing a custom sitting to help patients with swallowing disorders .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Functional oral intake scale (FOIS)
Adult sitting postural control measure (MCPAA)
Quality questionnaire of patient's life
Using Short Form (36) Health Survey (SF-36)
Full Information
NCT ID
NCT02457052
First Posted
April 9, 2015
Last Updated
July 11, 2019
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02457052
Brief Title
Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
Acronym
DATP-DEG
Official Title
Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
Keywords
Medical device
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DATP +
Arm Type
Experimental
Arm Description
Introduction of a device allowing a custom sitting to help patients with swallowing disorders .
Arm Title
DATP -
Arm Type
No Intervention
Arm Description
No introduction of a device allowing a custom sitting to help patients with swallowing disorders .
Intervention Type
Device
Intervention Name(s)
DATP
Intervention Description
Medical device allowing a custom sitting to help patients with swallowing disorders
Primary Outcome Measure Information:
Title
Change from baseline in laryngeal movement during swallowing
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
NIH Swallowing Safety Scale
Description
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.
Time Frame
One month
Title
Functional oral intake scale (FOIS)
Time Frame
One month
Title
Adult sitting postural control measure (MCPAA)
Time Frame
One month
Title
Quality questionnaire of patient's life
Description
Using Short Form (36) Health Survey (SF-36)
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie WOISARD, MD; PHD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Toulouse
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
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