Wheelchair Positioning and Neuromuscular Diseases

Neuromuscular Diseases Clinical Trial

— BDD-POSIT-MNM  

Official title:

Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006859
• Other study ID #: GHIV0321
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Groupement Hospitalier Intercommunal du Vexin
• Contact: Maryline Delattre
• Phone: +331.30.75.41.31
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Other:
• Cohorte
Assessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting

Locations

Country	Name	City	State
France	Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés	Aincourt
France	Clinique du Positionnement de l'AFM	Évry

Sponsors (2)

Lead Sponsor	Collaborator
Groupement Hospitalier Intercommunal du Vexin	Association Française contre les Myopathies (AFM), Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At the beginning and the end of the study, an average of 6 months
Secondary	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)	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
Secondary	Assessment of the incidence of pressure ulcers associated with sitting in NMD	Observation of the topography and the stage of ulcers associated with sitting	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
Secondary	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	At the end of the study, an average of 6 months
Secondary	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)	At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months