Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
ConditionNeuromuscular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
usual care
Other interventionFor each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation.
Treatment groups
368 Participants
are divided into 2 treatment groupsGroup A: development cohort1 intervention
Group B: validation cohort1 intervention
Trial outcomes
Primary outcomes
1
Change in the seating system of the user's wheelchair
Any change in the seating system of the user's wheelchair within 12 months will be noted. A change in the seating system is defined by the occurrence of at least one of these situations: * one or more seat/back adjustments: depth, width, height * addition/removal of postural elements * replacement of the cushion, or backrest or headrest * Use of electric functions of the wheelchair or on-board standing * modification of control device of the WC.
Time frame
through study completion, to 12 monthsSecondary outcomes
1
Seated Postural Control Measure (SPCM)
Seated Postural Control Measure (SPCM) is an instrument for the clinical assessment of seated postural control in adult clients using a locomotion aid. It therefore allows the evaluation of the two variables in inherent to postural control seated, i.e. the alignment of body segments and the influence between movement and posture. It also helps to assess changes of seated postural control due to the evolution over time or to an intervention of a adaptation of the sitting posture.
Time frame
at baseline and 12 months2
Pain Visual Analogue Scale
To assess pain, the investigators will use a Visual Analog Scale (0-10).
Time frame
at baseline and 12 months3
Pressure ulcer topography (stage and location )
International NPUAP/EPUAP Pressure injury classification system
Time frame
at baseline and 12 months4
Comfort perception scale (Visual Analogue Scale)
Visual Analog Scale (0-10) will be used to assess comfort of patients.
Time frame
at baseline and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov