Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: usual care.
- Who it may be relevant to
- Registry conditions: Neuromuscular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
Overview
Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).
Detailed description
Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits.
The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications.
In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation.
The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation.
Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation.
Interventions
- Other usual care
For each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation.
Primary outcome measures
- Change in the seating system of the user's wheelchair [Time frame: through study completion, to 12 months]
Secondary outcome measures (6)
- Seated Postural Control Measure (SPCM) [Time frame: at baseline and 12 months]
- Pain Visual Analogue Scale [Time frame: at baseline and 12 months]
- Pressure ulcer topography (stage and location ) [Time frame: at baseline and 12 months]
- Comfort perception scale (Visual Analogue Scale) [Time frame: at baseline and 12 months]
- Postural stability perception scale (in antero-posterior and lateral stability) [Time frame: at baseline and 12 months]
- adverse event [Time frame: through study completion, an average of 12 month]
Eligibility criteria
Inclusion criteria
- Male or female over the age of 18
- Daily wheelchair user (more than 4 hours per day)
- Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II
- Accompanied by an identified medical equipment provider, able to respond to the recommendations of the clinical team
- Patient informed and having signed consent.
Exclusion criteria
- Person who already has a seat change or FR prescription at the time of inclusion
- Having undergone surgery less than 1 year ago or a fracture
- Pregnant or breastfeeding women
- Patient under guardianship or curatorship.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- New technology Platform department, Raymond Poincaré Hospital, APHP — Garches
Identifiers
NCT: NCT05785546 · APHP210996 · 2023-A00831-44