Positioning in Wheelchair Bound Patients (AAPO'G)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurological Disease
• Intervention / Treatment: Procedure: Choice and adjustment of the wheelchair according to the patient's needs

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien PAGER; Email: julien.pager@fondation-hopale.org
• Study Contact Backup: Name: Marine Deseur; Phone Number: +33362882780; Email: marine.deseur@fondation-hopale.org

Study Locations

• France
  • Hauts DE France
    • Berck, Hauts DE France, France, 62608
      • Recruiting
      • Julien PAGER
      • Contact: Julien PAGER; Email: julien.pager@fondation-hopale.org
      • Principal Investigator: Jean Gabriel PREVINAIRE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients meeting the study eligibility criteria	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Evolution of the caregiver questionnaire score (Likert scale)		Day 0 therefore before the implementation of the positioning actions then at Day 7

Collaborators and Investigators

• Sponsor: FondationbHopale
• Collaborators: GHICL
• Investigators: Principal Investigator: Jean Gabriel PREVINAIRE, MD, Fondation Hopale

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 22, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: wheelchair; seating discomfort
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: HOP-RIPH2-21-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No