Wheelchair Positioning and Neuromuscular Diseases

Recruiting

• Conditions: Neuromuscular Diseases

• Registration Number: NCT05006859
• Lead Sponsor: Groupement Hospitalier Intercommunal du Vexin

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.

Study Timeline

• Study Start: 2021-05-17
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of postural wheelchair disorders in the neuromuscular disease population	At the beginning and the end of the study, an average of 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Comparison of pain associated with using the wheelchair	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months	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)
Assessment of the incidence of pressure ulcers associated with sitting in NMD	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months	Observation of the topography and the stage of ulcers associated with sitting
Assessment of the proportion of technical postural aids prescribed for patients who accept the positioning equipment	At the end of the study, an average of 6 months	Counts of the numbers of technical postural aids prescribed during consultation
Assessment of the technical postural aids efficacy	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months	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)

Trial Locations

Locations (2)

Clinique du Positionnement de l'AFM; 🇫🇷 Évry, France

Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés; 🇫🇷 Aincourt, France