NCT02457052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 5, 2025

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

April 9, 2015

Last Update Submit

November 27, 2025

Conditions

Deglutition Disorders

Keywords

Medical device

Outcome Measures

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.

    One month

Secondary Outcomes (4)

  • NIH Swallowing Safety Scale

    One month

  • Functional oral intake scale (FOIS)

    One month

  • Adult sitting postural control measure (MCPAA)

    One month

  • Quality questionnaire of patient's life

    One month

Study Arms (2)

DATP +

EXPERIMENTAL

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

Device: DATP

DATP -

NO INTERVENTION

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

Interventions

DATPDEVICE

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

DATP +

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 31586257RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Virginie WOISARD, MD; PHD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

May 29, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

December 5, 2025

Record last verified: 2019-07

Locations

FR(1)