Wheelchair Positioning and Neuromuscular Diseases

NCT05006859 | Recruiting

• 1 other identifier: GHIV0321
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular disease; Postural wheelchair disorders; Wheelchair positioning; Pain

Outcome Measures

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)

  At the beginning and the end of the study, an average of 6 months

Secondary Outcomes (4)

• 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 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

• 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

• 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

Interventions

Cohorte OTHER

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

Also known as: Questionnaire

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Groupement Hospitalier Intercommunal du Vexin: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator

Study Sites (2)

Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés

Aincourt, 95510, France

RECRUITING

Clinique du Positionnement de l'AFM

Évry, 91 000, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nadine Pellegrini

  Groupement Hospitalier Intercommunal du Vexin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline Delattre

CONTACT

+331.30.75.41.31; maryline.delattre@ght-novo.fr

Audrey Gilibert

CONTACT

+331.30.75.40.40; audrey.gilibert@ght-novo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 16, 2021
• Study Start: May 17, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

FR (2)