Clinical trial NCT05653089: Positioning in Wheelchair Bound Patients
Official title: Evaluation of Actions to Improve Positioning in Wheelchaire Bound Patients at Risk of Slipping : Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurological Disease
Keywords: wheelchair
seating discomfort
Lead sponsor: FondationbHopale
Sponsor class: OTHER
Collaborators: name: GHICL
First posted: 2022-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The choice of the most suitable chair as well as the improvement of the patient's positioning on this wheelchair is important to limit the discomfort, to prevent the risks of bedsores, the pains related to prolonged sitting and finally to support the interaction of the patient with its environment. The goal of this prospective, longitudinale, monocentric study is to evaluate the impact of standardized positioning in wheelchair-bound patients at risk of slipping.

The main questions on the positioning actions are:

* their actions impact of positioning actions on shear forces
* their impact on sliding in the chair
* their impact on the feeling of discomfort in the chair
* their impact on the caregivers' feelings about the patient's difficulties (eating, transfers, sliding)

Participation in this study will involve an increase in the number of transfers required for shear sheet placement and removal, as well as the time required for ischial measurement and the time to complete the (Tool for Assessing Wheelchair disComfort) TAWC questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized for a minimum of 9 days (minimum 48-hour reflection period after information)
* Patient aged between 18 and 80 years,
* Patient with a sitting time in a wheelchair \> or equal to 1 hour,
* Patient with a neurological condition : multiple sclerosis, stroke, spinal cord injury, Parkinson disease, neurodegenerative diseases...
* Patient informed of the study and having given his written consent,

Non inclusion Criteria:

* Cognitive disorders that do not allow the understanding of instructions
* Patient with a pressure sore
* Pregnant or breastfeeding woman
* Patient under legal protection

Primary outcomes:
measure: Evolution of shear measurement with the Shear® sensor
timeFrame: Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7
Secondary outcomes:
measure: Comparison of the sliding distance
timeFrame: Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7
measure: Evolution of the score on the TAWC scale
timeFrame: Day 0 therefore before the implementation of the positioning actions then at Day 7
measure: Evolution of the caregiver questionnaire score (Likert scale)
timeFrame: Day 0 therefore before the implementation of the positioning actions then at Day 7
Other outcomes:
Locations:
city: Berck
country: France
facility: Julien PAGER
state: Hauts DE France
Study officials:
affiliation: Fondation Hopale
name: Jean Gabriel PREVINAIRE, MD
role: PRINCIPAL_INVESTIGATOR
References: