Wheelchair Positioning and Neuromuscular Diseases
ConditionNeuromuscular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorGroupement Hospitalier Intercommunal du Vexin
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cohorte
Other interventionAssessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Description of postural wheelchair disorders in the neuromuscular disease population
Measurement of Posture by the tool: Measurement of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0) score (0 = normal, 1 = mild, 2 = moderated and 3 = severe)
Time frame
At the beginning and the end of the study, an average of 6 monthsSecondary outcomes
1
Comparison of pain associated with using the wheelchair
Assessment of initial pain (before positioning equipment) and pain after positioning equipment. Pain is assessed by a Simple Verbal Scale or by a Visual Analog Scale (0 to 10) (0 = no pain and 10 is the strongest pain)
Time frame
At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months2
Assessment of the incidence of pressure ulcers associated with sitting in NMD
Observation of the topography and the stage of ulcers associated with sitting
Time frame
At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months3
Assessment of the proportion of technical postural aids prescribed for patients who accept the positioning equipment
Counts of the numbers of technical postural aids prescribed during consultation
Time frame
At the end of the study, an average of 6 months4
Assessment of the technical postural aids efficacy
Comparison of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0) score before and after using of technical postural aids (0 = normal, 1 = mild, 2 = moderated and 3 = severe)
Time frame
At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Groupement Hospitalier Intercommunal du Vexin
Lead sponsor
Association Française contre les Myopathies (AFM), Paris
Collaborator
Source ClinicalTrials.gov