Neuromuscular DiseasesBDD-POSIT-MNMNCT05006859
Wheelchair Positioning and Neuromuscular Diseases
An observational study of Neuromuscular Diseases, run by Groupement Hospitalier Intercommunal du Vexin at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Cohorte
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 17 May 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier
Who may be able to join
- 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
Who cannot join
- Patient not seen in positioning consultation by N. Pellegrini and / or E. Dupitierr
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés
Aincourt, 95510
Nadine Pellegrini, Dr, +33 1 34 79 44 75, nadine.pellegrini@ght-novo.fr
- Recruiting
Clinique du Positionnement de l'AFM
Évry, 91 000
Elise Dupitier, +33 1 69 47 28 28, edupitier@afm-telethon.fr
About this study
Official title: 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).
Read the 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.
- Conditions
- Neuromuscular Diseases
- Being tested
- Cohorte
- Keywords
- Neuromuscular disease, Postural wheelchair disorders, Wheelchair positioning, Pain
- Medical subject headings
- Neuromuscular Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohorteOther
Also called Questionnaire
Assessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
Observation of the topography and the stage of ulcers associated with sitting
Measured: 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
Counts of the numbers of technical postural aids prescribed during consultation
Measured: At the end of the study, an average of 6 months
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)
Measured: At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start17 May 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupement Hospitalier Intercommunal du Vexin
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Responsible party
- Sponsor
- Investigators
- Nadine Pellegrini, Principal investigator, Groupement Hospitalier Intercommunal du Vexin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006859
- Sponsor's protocol ID
- GHIV0321
- Acronym
- BDD-POSIT-MNM
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)
- ClinicalTrials.gov ID
- NCT05006859
- Acronym / sponsor ID
- BDD-POSIT-MNM / GHIV0321
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular disease, Postural wheelchair disorders, Wheelchair positioning, Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Groupement Hospitalier Intercommunal du VexinUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Study start
- 17 May 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patient not seen in positioning consultation by N. Pellegrini and / or E. Dupitierr
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CohorteAlso: QuestionnaireAssessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting | Other | – |
Primary outcome
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)
4 secondary outcomes
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 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Pellegrini principal investigator
Groupement Hospitalier Intercommunal du Vexin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Groupement Hospitalier Intercommunal du Vexin at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline Delattre (+331.30.75.41.31, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.