Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System

Neuromuscular Diseases Clinical Trial

— BPIP-Score MNM  

Official title:

Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05785546
• Other study ID #: APHP210996
• Secondary ID: 2023-A00831-44
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: March 2028

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Samuel Pouplin, PhD
• Phone: + 33 (0)1.47.10.70.61
• Email: samuel.pouplin[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 368
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Other:
• usual care
For each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation.

Locations

Country	Name	City	State
France	New technology Platform department, Raymond Poincaré Hospital, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, to 12 months
Secondary	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.	at baseline and 12 months
Secondary	Pain Visual Analogue Scale	To assess pain, the investigators will use a Visual Analog Scale (0-10).	at baseline and 12 months
Secondary	Pressure ulcer topography (stage and location )	International NPUAP/EPUAP Pressure injury classification system	at baseline and 12 months
Secondary	Comfort perception scale (Visual Analogue Scale)	Visual Analog Scale (0-10) will be used to assess comfort of patients.	at baseline and 12 months
Secondary	Postural stability perception scale (in antero-posterior and lateral stability)	self-questionnaire will be used.	at baseline and 12 months
Secondary	adverse event	Semi-structured interview following the identification of an adverse event in wheelchair by the user, within 12 months after inclusion.; explain or understand the identification or not of an adverse event in wheelchair and its escalation to the clinical team, by the user.	through study completion, an average of 12 month