Development of a prognostic score for wheelchair seating changes
Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
Assistance Publique - Hôpitaux de Paris · NCT05785546
This study is trying to create a scoring system to help determine when people with neuromuscular diseases need changes in their wheelchair seating to stay healthy and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 368 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Garches) |
| Trial ID | NCT05785546 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and validating a prognostic score to assess the need for changes in wheelchair seating systems for individuals with neuromuscular diseases. It involves a prospective longitudinal multicenter cohort across eight centers, with four centers dedicated to developing the score and four for validation. The aim is to analyze seated postural installation in wheelchairs to prevent health complications and improve the quality of life for users. Occupational therapists and doctors of Physical Medicine and Rehabilitation will conduct assessments to inform necessary interventions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are daily wheelchair users with neuromuscular diseases like Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.
Not a fit: Patients who have recently undergone surgery, have a current seat change prescription, or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for wheelchair users by providing tailored recommendations for seating adjustments that prevent complications.
How similar studies have performed: While there is limited literature in this specific area, the approach of developing prognostic scores for wheelchair users is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Garches
- New technology Platform department, Raymond Poincaré Hospital, APHP — Garches, France (RECRUITING)
Study contacts
- Principal investigator: Samuel Pouplin, PhD — New technology Platform department, Raymond Poincaré Hospital, APHP
- Study coordinator: Samuel Pouplin, PhD
- Email: samuel.pouplin@aphp.fr
- Phone: + 33 (0)1.47.10.70.61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuromuscular Diseases