Neuromuscular DiseasesBPIP-Score MNMNCT05785546
Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
An observational study of Neuromuscular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases
- How many people
- 368 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2025to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.
Who may be able to join
- Male or female over the age of 18
- Daily wheelchair user (more than 4 hours per day)
- Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II
- Accompanied by an identified medical equipment provider, able to respond to the recommendations of the clinical team
- Patient informed and having signed consent.
Who cannot join
- Person who already has a seat change or FR prescription at the time of inclusion
- Having undergone surgery less than 1 year ago or a fracture
- Pregnant or breastfeeding women
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
New technology Platform department, Raymond Poincaré Hospital, APHP
Garches, 92380
About this study
Official title: Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).
Read the detailed description
Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits.
The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications.
In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation.
The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation.
Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation.
- Conditions
- Neuromuscular Diseases
- Being tested
- usual care
- Keywords
- Neuromuscular Diseases
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
For each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation.
| Study group | Role | What they receive |
|---|---|---|
| development cohort | Neuromuscular diseases Receives: Other: usual care | |
| validation cohort | Neuromuscular diseases Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the seating system of the user's wheelchair
Any change in the seating system of the user's wheelchair within 12 months will be noted.
A change in the seating system is defined by the occurrence of at least one of these situations:
- one or more seat/back adjustments: depth, width, height
- addition/removal of postural elements
- replacement of the cushion, or backrest or headrest
- Use of electric functions of the wheelchair or on-board standing
- modification of control device of the WC.
Measured: through study completion, to 12 months
Secondary outcomes (6)
Seated Postural Control Measure (SPCM)
Seated Postural Control Measure (SPCM) is an instrument for the clinical assessment of seated postural control in adult clients using a locomotion aid. It therefore allows the evaluation of the two variables in inherent to postural control seated, i.e. the alignment of body segments and the influence between movement and posture. It also helps to assess changes of seated postural control due to the evolution over time or to an intervention of a adaptation of the sitting posture.
Measured: at baseline and 12 months
Pain Visual Analogue Scale
To assess pain, the investigators will use a Visual Analog Scale (0-10).
Measured: at baseline and 12 months
Pressure ulcer topography (stage and location )
International NPUAP/EPUAP Pressure injury classification system
Measured: at baseline and 12 months
Comfort perception scale (Visual Analogue Scale)
Visual Analog Scale (0-10) will be used to assess comfort of patients.
Measured: at baseline and 12 months
Postural stability perception scale (in antero-posterior and lateral stability)
self-questionnaire will be used.
Measured: at baseline and 12 months
adverse event
Semi-structured interview following the identification of an adverse event in wheelchair by the user, within 12 months after inclusion.
explain or understand the identification or not of an adverse event in wheelchair and its escalation to the clinical team, by the user.
Measured: through study completion, an average of 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start19 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Pouplin, PhD, Principal investigator, New technology Platform department, Raymond Poincaré Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785546
- Sponsor's protocol ID
- APHP210996
- Other IDs
- 2023-A00831-44
- Acronym
- BPIP-Score MNM
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2023
- Last updated
- 19 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
- ClinicalTrials.gov ID
- NCT05785546
- Acronym / sponsor ID
- BPIP-Score MNM / APHP210996
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Mar 2023 (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.
Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).
Detailed description
Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits.
The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications.
In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation.
The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation.
Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| development cohort | – | Other: usual careNeuromuscular diseases |
| validation cohort | – | Other: usual careNeuromuscular diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.
Key inclusion criteria (5 listed)
- Male or female over the age of 18
- Daily wheelchair user (more than 4 hours per day)
- Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II
- Accompanied by an identified medical equipment provider, able to respond to the recommendations of the clinical team
- Patient informed and having signed consent.
Key exclusion criteria (4 listed)
- Person who already has a seat change or FR prescription at the time of inclusion
- Having undergone surgery less than 1 year ago or a fracture
- Pregnant or breastfeeding women
- Patient under guardianship or curatorship.
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 |
|---|---|---|
| usual careFor each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation. | Other | development cohort, validation cohort |
Primary outcome
Change in the seating system of the user's wheelchair
Time frame: through study completion, to 12 months
Any change in the seating system of the user's wheelchair within 12 months will be noted. A change in the seating system is defined by the occurrence of at least one of these situations: * one or more seat/back adjustments: depth, width, height * addition/removal of postural elements * replacement of the cushion, or backrest or headrest * Use of electric functions of the wheelchair or on-board standing * modification of control device of the WC.
6 secondary outcomes
Seated Postural Control Measure (SPCM)
Time frame: at baseline and 12 months
Pain Visual Analogue Scale
Time frame: at baseline and 12 months
Pressure ulcer topography (stage and location )
Time frame: at baseline and 12 months
Comfort perception scale (Visual Analogue Scale)
Time frame: at baseline and 12 months
Postural stability perception scale (in antero-posterior and lateral stability)
Time frame: at baseline and 12 months
adverse event
Time frame: through study completion, an average of 12 month
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 19 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.
Samuel Pouplin, PhD principal investigator
New technology Platform department, Raymond Poincaré Hospital, APHP
1 site 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 Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 4 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 19 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 1 site 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 Samuel Pouplin, PhD (+ 33 (0)1.47.10.70.61, samuel.pouplin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the seating system of the user's wheelchair (time frame: through study completion, to 12 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 19 Mar 2025.