Positioning in Wheelchair Bound Patients

Neurological Disease Clinical Trial

— AAPO'G  

Official title:

Evaluation of Actions to Improve Positioning in Wheelchaire Bound Patients at Risk of Slipping : Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653089
• Other study ID #: HOP-RIPH2-21-05
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: April 2023
• Source: FondationbHopale
• Contact: Marine Deseur
• Phone: +33362882780
• Email: marine.deseur[@]fondation-hopale.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 22, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disease

Intervention

Procedure:
• Choice and adjustment of the wheelchair according to the patient's needs
After a personalized analysis of the patient and his needs, the occupational therapists define the equipment necessary for the good positioning of the patient: Choice and adjustments of the wheelchair Choice and adjustments of the wheelchair/patient interface

Locations

Country	Name	City	State
France	Julien PAGER	Berck	Hauts DE France

Sponsors (2)

Lead Sponsor	Collaborator
FondationbHopale	GHICL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of shear measurement with the Shear® sensor	Shear will be measured over a period of one hour (shear evolution over one hour), during which the patient will follow a standardized activity program.	Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7
Secondary	Comparison of the sliding distance	The sliding distance is measured by the position of the ischiums. It is the difference between the position measured before and after 1 hour of standardized activities.	Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7
Secondary	Evolution of the score on the TAWC scale	The TAWC (Tool for Assessing Wheelchair discomfort) scale assesses 2 discomfort scores: an assessment of general discomfort, based on 13 items scored on 7 points; an evaluation of the intensity of the discomfort, based on 9 items from 0 to 10.	Day 0 therefore before the implementation of the positioning actions then at Day 7
Secondary	Evolution of the caregiver questionnaire score (Likert scale)		Day 0 therefore before the implementation of the positioning actions then at Day 7