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NCT Number: NCT05006859

Wheelchair Positioning and Neuromuscular Diseases

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).

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Key information

Conditions

Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohorte

Other

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

Other names: Questionnaire

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey Gilibert

CONTACT

[email protected]

+331.30.75.40.40 ext. 72.57

Maryline Delattre

CONTACT

[email protected]

+331.30.75.41.31

Sponsors and collaborators

Lead sponsor

Groupement Hospitalier Intercommunal du Vexin

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris

Registry information

Official study title

Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)

Acronym: BDD-POSIT-MNM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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