NCT05653089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

August 31, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

November 10, 2022

Last Update Submit

August 30, 2023

Conditions

Neurological Disease

Keywords

wheelchairseating discomfort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Comparison of the sliding distance

    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

    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

Study Arms (1)

All patients meeting the study eligibility criteria

EXPERIMENTAL
Procedure: Choice and adjustment of the wheelchair according to the patient's needs

Interventions

Choice and adjustment of the wheelchair according to the patient's needsPROCEDURE

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

All patients meeting the study eligibility criteria

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julien PAGER

Berck, Hauts-de-France, 62608, France

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Jean Gabriel PREVINAIRE, MD

    Fondation Hopale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Deseur

CONTACT

+33362882780marine.deseur@fondation-hopale.org

Julien PAGER

CONTACT

julien.pager@fondation-hopale.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

December 16, 2022

Study Start

October 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 22, 2023

Last Updated

August 31, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)