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Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders (DATP-DEG)

T

Toulouse University Hospital

Status

Completed

Conditions

Deglutition Disorders

Treatments

Device: DATP

Study type

Interventional

Funder types

Other

Identifiers

NCT02457052
ID-RCB: 2013-A01351-44 (Registry Identifier)
12 558 15

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

DATP +
Experimental group
Description:
Introduction of a device allowing a custom sitting to help patients with swallowing disorders .
Treatment:
Device: DATP
DATP -
No Intervention group
Description:
No introduction of a device allowing a custom sitting to help patients with swallowing disorders .

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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