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CompletedNCT02457052DATP-DEGUpdated Dec 5, 2025

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

An interventional study of DATP in Deglutition Disorders, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Deglutition Disorders

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Keywords

  • Medical device
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In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    DATP +

    Introduction of a device allowing a custom sitting to help patients with swallowing disorders .

    Device: DATP

  • No intervention
    DATP -

    No introduction of a device allowing a custom sitting to help patients with swallowing disorders .

Interventions

  • DeviceDATP

    Medical device allowing a custom sitting to help patients with swallowing disorders

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: One month

Secondary outcomes

  1. 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.

    Time frame: One month

  2. Functional oral intake scale (FOIS)

    Time frame: One month

  3. Adult sitting postural control measure (MCPAA)

    Time frame: One month

  4. Quality questionnaire of patient's life

    Using Short Form (36) Health Survey (SF-36)

    Time frame: One month

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Study locations

1 site
  • University Hospital, Toulouse
    Toulouse, Midi-Pyrénées 31059, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02457052
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
May 29, 2015
Start date
Oct 2014
Primary completion
Mar 2017
Completion
Mar 2018
Last update
Dec 5, 2025

Study contacts

Virginie WOISARD, MD; PHD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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