Clinical trial NCT05006859: Wheelchair Positioning and Neuromuscular Diseases
Official title: Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Diseases
Keywords: Neuromuscular disease
Postural wheelchair disorders
Wheelchair positioning
Pain
Lead sponsor: Groupement Hospitalier Intercommunal du Vexin
Sponsor class: OTHER
Collaborators: name: Association Française contre les Myopathies (AFM), Paris
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier

Brief summary: This database will describe sitting postural control in wheelchair, as well as PW pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (NMD).

Detailed description: Neuromuscular diseases are genetic diseases of the muscle or its innervation (nerve connection) causing respiratory, cardiac and especially motor difficulties which may require use of wheelchair. However there is no standardized positioning protocol, so it seems interesting to us to study wheelchair positioning in neuromuscular diseases).

The purpose of this study is to describe sitting posture in the wheelchair in patients with neuromuscular disease, pain associated with using the wheelchair, but also to assess the effectiveness of the recommended equipment making the same evaluations in follow-up consultation (a few months after receipt of the prescribed TAP).

Posture is assessed by the tool: Measurement of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0), which is a validated tool.

Pain is assessed by a Simple Verbal Scale or by a Visual Analog Scale. This database could allow providing guidelines of good practice, for wheelchair positioning for patients with neuromuscular disease.

Eligibility criteria: Inclusion Criteria :

* Patient with neuromuscular disease
* Written informed consent (IC) obtained
* Adult patients (\> 18 years) Or
* Adults under guardianship who has given theirs oral consent and guardian's consent obtained Or
* Childs who has given theirs oral consent and parents' consent obtained
* Wheelchair user

Exclusion Criteria :

• Patient not seen in positioning consultation by N. Pellegrini and / or E. Dupitierr

Primary outcomes:
measure: Description of postural wheelchair disorders in the neuromuscular disease population
timeFrame: At the beginning and the end of the study, an average of 6 months
Secondary outcomes:
measure: Comparison of pain associated with using the wheelchair
timeFrame: At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
measure: Assessment of the incidence of pressure ulcers associated with sitting in NMD
timeFrame: At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
measure: Assessment of the proportion of technical postural aids prescribed for patients who accept the positioning equipment
timeFrame: At the end of the study, an average of 6 months
measure: Assessment of the technical postural aids efficacy
timeFrame: At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
Other outcomes:
Locations:
city: Aincourt
country: France
facility: Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés
city: Évry
country: France
facility: Clinique du Positionnement de l'AFM
Study officials:
affiliation: Groupement Hospitalier Intercommunal du Vexin
name: Nadine Pellegrini
role: PRINCIPAL_INVESTIGATOR
References: