Deglutition DisordersDATP-DEGNCT02457052
Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
A study testing DATP in people with Deglutition Disorders, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- DATP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Deglutition Disorders
- Being tested
- DATP
- Keywords
- Medical device
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DATPDevice
Medical device allowing a custom sitting to help patients with swallowing disorders
| Study group | Role | What they receive |
|---|---|---|
| DATP + | Experimental | Introduction of a device allowing a custom sitting to help patients with swallowing disorders . Receives: Device: DATP |
| DATP - | No intervention | No introduction of a device allowing a custom sitting to help patients with swallowing disorders . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (4)
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.
Measured: One month
Functional oral intake scale (FOIS)
Measured: One month
Adult sitting postural control measure (MCPAA)
Measured: One month
Quality questionnaire of patient's life
Using Short Form (36) Health Survey (SF-36)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie WOISARD, MD; PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457052
- Sponsor's protocol ID
- 12 558 15
- Other IDs
- ID-RCB: 2013-A01351-44
- Acronym
- DATP-DEG
- Status last verified
- Jul 2019
- First submitted
- 9 Apr 2015
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Woisard V, Costes M, Colineaux H, Lepage B. How a personalised transportable folding device for seating impacts dysphagia. Eur Arch Otorhinolaryngol. 2020 Jan;277(1):179-188. doi: 10.1007/s00405-019-05657-5. Epub 2019 Oct 4.
PubMed 31586257
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
- ClinicalTrials.gov ID
- NCT02457052
- Acronym / sponsor ID
- DATP-DEG / 12 558 15
- Conditions
- Deglutition Disorders
- Keywords
- Medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DATP + | Experimental | Device: DATPIntroduction of a device allowing a custom sitting to help patients with swallowing disorders . |
| DATP - | No intervention | –No introduction of a device allowing a custom sitting to help patients with swallowing disorders . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DATPMedical device allowing a custom sitting to help patients with swallowing disorders | Device | DATP + |
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.
4 secondary outcomes
NIH Swallowing Safety Scale
Time frame: One month
Functional oral intake scale (FOIS)
Time frame: One month
Adult sitting postural control measure (MCPAA)
Time frame: One month
Quality questionnaire of patient's life
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 31586257Woisard V, Costes M, Colineaux H, Lepage B. How a personalised transportable folding device for seating impacts dysphagia. Eur Arch Otorhinolaryngol. 2020 Jan;277(1):179-188. doi: 10.1007/s00405-019-05657-5. Epub 2019 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie WOISARD, MD; PHD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DATP in people with Deglutition Disorders, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in laryngeal movement during swallowing (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.