Clinical trial NCT05785546: Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
Official title: Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Diseases
Keywords: Neuromuscular Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.

Brief summary: 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.

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.

Primary outcomes:
measure: Change in the seating system of the user's wheelchair
timeFrame: through study completion, to 12 months
Secondary outcomes:
measure: Seated Postural Control Measure (SPCM)
timeFrame: at baseline and 12 months
measure: Pain Visual Analogue Scale
timeFrame: at baseline and 12 months
measure: Pressure ulcer topography (stage and location )
timeFrame: at baseline and 12 months
measure: Comfort perception scale (Visual Analogue Scale)
timeFrame: at baseline and 12 months
measure: Postural stability perception scale (in antero-posterior and lateral stability)
timeFrame: at baseline and 12 months
measure: adverse event
timeFrame: through study completion, an average of 12 month
Other outcomes:
Locations:
city: Garches
country: France
facility: New technology Platform department, Raymond Poincaré Hospital, APHP
Study officials:
affiliation: New technology Platform department, Raymond Poincaré Hospital, APHP
name: Samuel Pouplin, PhD
role: PRINCIPAL_INVESTIGATOR
References: