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OpenTrials
Completed

NCT Number: NCT02457052

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

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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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DATP

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. NIH Swallowing Safety Scale

    Time frame: One month

    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.

  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

    Time frame: One month

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: DATP-DEG

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 29, 2015
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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