Wheelchair Positioning and Neuromuscular Diseases (BDD-POSIT-MNM)

March 10, 2025 updated by: Groupement Hospitalier Intercommunal du Vexin

Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aincourt, France, 95510
        • Recruiting
        • Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés
        • Contact:
      • Évry, France, 91 000
        • Recruiting
        • Clinique du Positionnement de l'AFM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of postural wheelchair disorders in the neuromuscular disease population
Time Frame: 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)
At the beginning and the end of the study, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pain associated with using the wheelchair
Time Frame: 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)
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
Time Frame: 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
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
Time Frame: At the end of the study, an average of 6 months
Counts of the numbers of technical postural aids prescribed during consultation
At the end of the study, an average of 6 months
Assessment of the technical postural aids efficacy
Time Frame: 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)
At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupement Hospitalier Intercommunal du Vexin

Collaborators

Association Française contre les Myopathies (AFM), Paris

Investigators

  • Principal Investigator: Nadine Pellegrini, Groupement Hospitalier Intercommunal du Vexin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHIV0321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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