AAPO'G: POSITIONING IN WHEELCHAIR BOUND PATIENTS

Sponsor
FondationbHopale (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653089
Collaborator
GHICL (Other)
30
1
1
12.2
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Choice and adjustment of the wheelchair according to the patient's needs
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
EVALUATION OF ACTIONS TO IMPROVE POSITIONING IN WHEELCHAIR BOUND PATIENTS AT RISK OF SLIPPING : PILOT STUDY
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 22, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evolution of shear measurement with the Shear® sensor [Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7]

    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.

Secondary Outcome Measures

  1. Comparison of the sliding distance [Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7]

    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.

  2. Evolution of the score on the TAWC scale [Day 0 therefore before the implementation of the positioning actions then at Day 7]

    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.

  3. Evolution of the caregiver questionnaire score (Likert scale) [Day 0 therefore before the implementation of the positioning actions then at Day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Julien PAGER Berck Hauts DE France France 62608

Sponsors and Collaborators

  • FondationbHopale
  • GHICL

Investigators

  • Principal Investigator: Jean Gabriel PREVINAIRE, MD, Fondation Hopale

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FondationbHopale
ClinicalTrials.gov Identifier:
NCT05653089
Other Study ID Numbers:
  • HOP-RIPH2-21-05
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FondationbHopale
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022