Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System

NCT05785546 | Recruiting

• 2 other identifiers: APHP2109962023-A00831-44
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, to 12 months

Secondary Outcomes (6)

• Seated Postural Control Measure (SPCM)

  at baseline and 12 months

• Pain Visual Analogue Scale

  at baseline and 12 months

• Pressure ulcer topography (stage and location )

  at baseline and 12 months

• Comfort perception scale (Visual Analogue Scale)

  at baseline and 12 months

• Postural stability perception scale (in antero-posterior and lateral stability)

  at baseline and 12 months

Study Arms (2)

development cohort

Neuromuscular diseases

Other: usual care

validation cohort

Neuromuscular diseases

Other: usual care

Interventions

usual care OTHER

For each cohort, the patient is seen at least twice, during annual visits in multidisciplinary consultation.

development cohort; validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II.

You may qualify if:

• 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.

You may not qualify if:

• Having undergone surgery less than 1 year ago or a fracture
• Pregnant or breastfeeding women
• Patient under guardianship or curatorship.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

New technology Platform department, Raymond Poincaré Hospital, APHP

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Samuel Pouplin, PhD

  New technology Platform department, Raymond Poincaré Hospital, APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Pouplin, PhD

CONTACT

+ 33 (0)1.47.10.70.61; samuel.pouplin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: February 19, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

FR (1)